Contract Role
100 % Onsite
Up to $60/hr. W2
Position Summary
The Lead Discovery and Structural Biology Department within client is seeking a highly qualified Protein Expression & Purification Scientist (Contractor) with demonstrated expertise in molecular biology, heterologous protein expression, and protein purification. The successful candidate will contribute to research programs within an industry-leading drug discovery environment leveraging access to state-of-the-art protein expression and purification platforms. Responsibilities include executing expression workflows in baculovirus expression vector systems (BEVS)/insect cells, as well as in E. coli, including high-throughput (HTP) small-scale expression screening, followed by downstream purification and analytical characterization. Experience with biophysical methods is considered an asset.
Essential Duties and Responsibilities
Perform molecular biology workflows, including:Cloning, vector design, construct optimization, and sequence verificationPCR, primer design, restriction‐based, and recombination‐based cloningExecute protein expression using:BEVS/insect cell systems, including virus generation, amplification, and expression optimizationE. coli expression, including IPTG‐induced and auto‐induction strategiesHigh‐throughput (HTP) small‐scale expression testing for rapid screening of constructs and conditionsConduct purification of recombinant proteins using standard chromatographic techniques (affinity, ion exchange, size‐exclusion chromatography).Optimize expression constructs, culture conditions, and purification workflows to achieve the required yield, purity, and quality.Perform analytical characterization, including SDS‐PAGE, Western blotting, SEC, and other relevant assays.Maintain accurate and complete laboratory records in accordance with internal documentation standards (experience with Benchling is a plus).Communicate experimental results, observations, and recommendations to team members in a clear and timely manner.Adhere to all laboratory safety policies and organizational compliance requirements.Education and Experience
Bachelor’s degree in Biochemistry, Molecular Biology, Structural Biology, or related field with 3+ years of relevant industry experience, orMaster’s degree with 1+ year of relevant industry experienceStrong molecular biology and cloning expertise is required.Proven track record of protein expression in BEVS/insect systems and E. coli, including HTP small‐scale expression screening.Demonstrated proficiency in chromatographic purification and method development.Experience with biophysical characterization techniques (e.g., LC‐MS, SPR, MST, SEC‐MALS, nanoDSF, mass photometry) is preferred but not required.Company Descriptionwww.techdataservice.comCompany Descriptionwww.techdataservice.com Read LessProject Manager (Non Technical)
MUST HAVES:
1. Strong Microsoft office skills
2. Communication skills and experience
3. Organizational & PM skills and High attention to detail
Position Title: Non-technical Project Manager
Overview
The Project Manager supports Project teams and Project Leads by ensuring delivery of tasks and deliverables executed according to project specifications incl. budget, timelines, and scope. This role is highly cross-functional.
Project Execution:
Supports the integration lead by executing on tasks/ workstreams in line with the integration lead expectationsStructures issues once identified. Can apply hypotheses and structure problem solving sessionsPrepares project plans with draft milestones and meets deadlines (high quality output) with support from the integration leadFacilitates data gathering and captures notes from interviews with internal and external input providersWith some guidance, demonstrates an ability to structure and execute on quantitative and qualitative analyses and support development of recommendationsPrepares slides using conscious application of structured communication approaches (e.g. top-down vs. bottom-up)Creates project structure via minutes, scheduling necessary project meetings, ensures appropriate meeting cadence, etc.Requirements:
A Bachelor's in commercial, economic, scientific, or a related field is required.1-year professional relevant experience preferredWorking understanding of pharmaceutical industry and Mergers & Acquisitions is a plusProject and/or consulting experience is a plusGood presentation skillsAptitude for creating structured top-down written and oral communicationGood analytical visualization skillsProficient in using PC tools (PowerPoint and Excel) is required with an interest to improve speed and capabilitiesStrong language skills in English (written and orally)Flexible in terms of working under tight deadlines and ambiguity/ changing circumstancesTechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Company Descriptionwww.techdataservice.comCompany Descriptionwww.techdataservice.com Read LessProject Manager (Non Technical) –
MUST HAVES:
1. Strong Microsoft office skills
2. Communication skills and experience
3. Organizational & PM skills and High attention to detail
Position Title: Non-technical Project Manager
Overview
The Project Manager supports Project teams and Project Leads by ensuring delivery of tasks and deliverables executed according to project specifications incl. budget, timelines, and scope. This role is highly cross-functional.
Project Execution:
Supports the integration lead by executing on tasks/ workstreams in line with the integration lead expectationsStructures issues once identified. Can apply hypotheses and structure problem solving sessionsPrepares project plans with draft milestones and meets deadlines (high quality output) with support from the integration leadFacilitates data gathering and captures notes from interviews with internal and external input providersWith some guidance, demonstrates an ability to structure and execute on quantitative and qualitative analyses and support development of recommendationsPrepares slides using conscious application of structured communication approaches (e.g. top-down vs. bottom-up)Creates project structure via minutes, scheduling necessary project meetings, ensures appropriate meeting cadence, etc.Requirements:
A Bachelor's in commercial, economic, scientific, or a related field is required.1-year professional relevant experience preferredWorking understanding of pharmaceutical industry and Mergers & Acquisitions is a plusProject and/or consulting experience is a plusGood presentation skillsAptitude for creating structured top-down written and oral communicationGood analytical visualization skillsProficient in using PC tools (PowerPoint and Excel) is required with an interest to improve speed and capabilitiesStrong language skills in English (written and orally)Flexible in terms of working under tight deadlines and ambiguity/ changing circumstancesTechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Company Descriptionwww.techdataservice.comCompany Descriptionwww.techdataservice.com Read LessProject Manager (Non Technical) –
MUST HAVES:
1. Strong Microsoft office skills
2. Communication skills and experience
3. Organizational & PM skills and High attention to detail
Position Title: Non-technical Project Manager
Overview
The Project Manager supports Project teams and Project Leads by ensuring delivery of tasks and deliverables executed according to project specifications incl. budget, timelines, and scope. This role is highly cross-functional.
Project Execution:
Supports the integration lead by executing on tasks/ workstreams in line with the integration lead expectationsStructures issues once identified. Can apply hypotheses and structure problem solving sessionsPrepares project plans with draft milestones and meets deadlines (high quality output) with support from the integration leadFacilitates data gathering and captures notes from interviews with internal and external input providersWith some guidance, demonstrates an ability to structure and execute on quantitative and qualitative analyses and support development of recommendationsPrepares slides using conscious application of structured communication approaches (e.g. top-down vs. bottom-up)Creates project structure via minutes, scheduling necessary project meetings, ensures appropriate meeting cadence, etc.Requirements:
A Bachelor's in commercial, economic, scientific, or a related field is required.1-year professional relevant experience preferredWorking understanding of pharmaceutical industry and Mergers & Acquisitions is a plusProject and/or consulting experience is a plusGood presentation skillsAptitude for creating structured top-down written and oral communicationGood analytical visualization skillsProficient in using PC tools (PowerPoint and Excel) is required with an interest to improve speed and capabilitiesStrong language skills in English (written and orally)Flexible in terms of working under tight deadlines and ambiguity/ changing circumstancesTechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Company Descriptionwww.techdataservice.comCompany Descriptionwww.techdataservice.com Read LessSecurity Engineer- W2 Only – On site -BB330
BB330
Alameda, CA
3+ Months
JOB DESCRIPTION
SUMMARY/JOB PURPOSE:
The Security Engineer will support the Zero Trust Engineering team in strengthening the security posture of Client’ corporate systems, cloud environments, and infrastructure. This role will support identity security and secure access operations across enterprise platforms. This role will focus on service account management using Silverfort, integration with Active Directory, Microsoft Entra ID, and other identity platforms, operational support for AI-related and other security projects, and ongoing administration of Zscaler assets in AWS.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
· Manage and support service accounts and other non-human identities using Silverfort, including discovery, policy implementation, monitoring, access reviews, and lifecycle governance.
· Assist with integration and operational support across Active Directory, Microsoft Entra ID, and other enterprise identity platforms to strengthen identity visibility, authentication controls, and access governance.
· Contribute to AI-related and other enterprise security projects, particularly where identity, authentication, access control, or service account usage is involved.
· Maintain and administer Zscaler App Connectors, including health monitoring, troubleshooting, patching, version upgrades, and operational maintenance.
· Develop, update, and maintain runbooks, standard operating procedures, and technical documentation for identity and Zscaler-related operations.
· Plan, document, and support disaster recovery drills involving Zscaler, ensuring procedures are tested, repeatable, and aligned with business continuity requirements.
· Work closely with security, infrastructure, cloud, and application teams to implement changes, resolve issues, and improve operational resilience.
· Provide troubleshooting support, issue analysis, and recommendations for service account security, identity integrations, and Zscaler-related incidents.
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education:
BS/BA degree in Cybersecurity, Computer Science, Information Technology, or related discipline; or Equivalent combination of education, training, and hands-on experience.
Experience:
Hands-on experience for service account life cycle management or identity security use cases.
Strong knowledge of Active Directory, Microsoft Entra ID, and enterprise identity and access management concepts.
Experience supporting Zscaler, especially App Connectors, including patching, upgrades, and operational troubleshooting.
Experience writing and maintaining technical runbooks and operational procedures.Ability to support disaster recovery testing, system maintenance, and cross-functional security projects.
Strong documentation, communication, and problem-solving skills.
Familiarity with security tools or cloud platforms is advantageous but not required.
Experience in a regulated or compliance-driven environment is a plus.
Experience in AI/ML systems
Knowledge/Skills:
Foundational knowledge of networking (TCP/IP, DNS, routing), operating systems (Windows,Linux), and security fundamentals.Identity troubleshooting and root cause analysis.Basic understanding of threat vectors, attacker techniques, and defensive countermeasures.Ability to analyze logs and troubleshoot basic security or system issues.Familiarity with scripting (Python, PowerShell) is a plus.Strong written and verbal communication skills, with the ability to articulate technical topicsclearly.non-technical staff.
Strong customer service orientation and ability to work collaboratively with technical andAbility to prioritize tasks, follow procedures, and adapt to changing priorities.Demonstrated curiosity, eagerness to learn, and willingness to take on new challenges.WORKING CONDITIONS:Primarily working indoors in office scenarios.
Occasional after-hours support may be required for critical issues.
TechData is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.
Company Descriptionwww.techdataservice.comCompany Descriptionwww.techdataservice.com Read LessJob Title: QC Analyst
Location: Cincinnati, OH
Job ID: 9916
Pay Rate: Up to $32/hr.
Contract: 6 Months (Renewable)
Shift Schedule: Monday - Friday (8:00am - 5:00pm)
Core essential skill sets candidates must have to be considered for the role:
1. BS or higher in science related discipline, chemistry is preferred
2. Lab experience
3. Recent College graduates are welcomed.
4. Experience with compenial testing.
5. Wet chemistry techniques.
Job Description
Perform routine and non-routine chemical testing of commercial, validation and stability samples in accordance to written methodology Perform qualitative and quantitative analyses using analytical instrumentation such as HPLC; GC, UV/Vis, KF and FTIR. Utilize electronic laboratory information systems such as LIMS and Empower for acquisition and processing of analytical data Analyze data against approved specifications, notifying management of any OOS and aberrant resultsActively participate in root cause problem solving during laboratory investigations, provide input for effective corrective and preventive actionsPerform routine maintenance on lab equipment, as neededPerform peer review of laboratory testing, as requiredBasic knowledge and understanding of USP, cGMP, and FDA regulationsCreate and maintain lab record documentation (notebooks and computer based) according to GMPs and GLPsDemonstrate the philosophy of Right First Time Maintain a clean and safe work environment and follow safety procedures and policies.Provide feedback on systems and processes to promote continuous improvement and champion selected changesGrow in the job, accountable for establishing and accomplishing annual personal development goals Contribute to department and site goalsCommunicate clearly and well within a team environmentParticipate in daily direction setting huddles to provide feedback and ensure alignment on daily/weekly/monthly objectives Shares information with others – keeping management informed and helping department to meet the goalsActively participate in regular one-on-one meetings with direct managerCommunicate external to the department, where applicableCollaborate effectively to achieve team and organizational goalsPrioritize assigned work to maximize time and equipment efficiencyWork independently with limited supervision for routine assignmentsTroubleshoot problems encountered with methods and instruments - routinely solve, choosing among clearly defined alternativesResponsible for the accurate, timely and compliant execution of assigned projects, analytical testing and related documentationClient: Large Pharma
Location: Remote or Hybrid (Titusville, NJ)
Job ID: 71741
Job Title: Scientist 4 – Informatics
Pay Rate: $63 /hr. W2 with TechData
Job Length: 1 Year (Renewable)
- Role can be HYBRID or REMOTE, HOWEVER required to be local to PA or NJ so they can drive into a client location with no commuting issues when it is required
- Role can be HYBRID or REMOTE, but must be in EST time zone, prefers the candidate lives in NJ or PA
- Masters degree is required
- Required experience with Python and SQL - REQUIRED
- Must have MSAT or Manufacturing background
- Will work on a major project, will help setup connections, and explore data analysis
- Will research specific materials
- Must be a critical thinker
- Must be eager to learn
- MUST HAVE PROGRAMMING AND CODING EXPERIENCE
- Will help with coming up with unique ways to solve problems or obstacles
- Must have hands on coding experience (versus using AI solutions)
Senior Scientist
MSAT Material Science is seeking a scientist to drive raw material quality and traceability initiatives that support regulatory compliance and dependable manufacturing outputs. This candidate will provide technical support to the MSAT Material Science team on a variety of deliverables critical to successful technical materials deliverables. This role will support a range of activities including investigations, specification development, material qualification, change control and technology transfer support, analytical method evaluation and data driven traceability efforts. The role will collaborate closely with Process, Planning, Manufacturing, Quality, Supply Chain/Procurement, Supplier Quality, and IT/data teams to improve raw material traceability, resolve material issues, and produce regulatory quality documentation.
Key responsibilities
Support the MSAT Material Science team on material related investigations and deviation analyses: gather and analyze manufacturing and analytical data, contribute to technical assessments, and help implement solutions as applicable.Assist MSAT Material Science in developing and revising raw material specifications: draft language, define acceptance criteria, compile technical justification, compendial review and coordinate SME deliverables.Support material qualification and requalification activities on behalf of the MSAT Material Science team: prepare qualification plans/protocols, coordinate testing with internal or external labs/vendors, analyze returned data, and draft qualification reports.Provide technical input for change controls: prepare technical assessments, perform impact and risk evaluations, coordinate verification/validation activities, and compile evidence for closure.Support technology transfer activities: prepare transfer documentation, align material requirements between development and manufacturing, and coordinate post transfer monitoring and follow up.Contribute to material traceability and data mapping initiatives: work with Process, Planning, and IT/data teams to map raw material usage to manufacturing campaigns and produce actionable visualizations.Interface with Supplier Quality and Procurement to support vendor qualification, incoming material review, sample evaluations, and supplier investigations.Prepare and maintain regulatory grade documentation on behalf of MSAT Material Science: investigation summaries, specifications, test method rationales, SOPs, qualification packages, and technical reports.Support audits and inspections by preparing evidence, supporting response to technical queries, and assisting in closure of material related findings under Quality oversight.Communicate findings and recommendations to the MSAT Material Science team, cross functional partners, and leadership; present at technical meetings as required.Mentor and guide junior staff, contractors, or interns on data review, documentation standards, and investigation best practices.Qualifications
Advanced degree in Materials Science, Chemical Engineering, Chemistry, Polymer Science, or closely related discipline preferred; Master's with 3-5+ years experience. PhD with 0-3+ years experience.Experience coordinating testing with external/internal analytical labs and interpreting lab reports.Knowledge of GMP principles, validation strategies, and risk assessment methodologies (e.g., FMEA).Familiarity with supplier qualification practices and vendor communications.Demonstrated experience supporting material investigations, specification setting, qualification oversight, change control, and tech transfer in a regulated manufacturing environment (pharma, biotech, medical device, or related) preferred.Strong data analysis skills and ability to synthesize manufacturing and analytical datasets to support root cause and risk assessments.Proven technical writing skills for regulatory grade reports, specifications, and protocols.Experience collaborating with Process, Planning, Manufacturing, Quality, Supply Chain/Procurement, Supplier Quality, and IT/data teams.Familiarity with electronic quality systems (eQMS, LIMS), manufacturing systems (MES), SAP and common data tools (Excel, Python/R, JMP, or similar).Prior industry experience in MSAT or material science support roles within regulated manufacturing preferred.Pay: $53.00 - $63.00 per hour
Work Location: Remote
Company Descriptionwww.techdataservice.comCompany Descriptionwww.techdataservice.com Read LessPay: $87.00 - $107.00 per hour
Job description:
Contract: 7 Months (Renewable)
Job ID: 10171
Strong hands-on experience with LabWare 8 configuration or technical development
Experience in configuring Raw Material Workflows in Labware or Instrument/Equipment integration (Empower/LabX to Labware) preferredExperience with previous LabWare versions is not acceptable, as they differ from LabWare 8Not seeking candidates whose experience is limited to Business Analyst, Project Management, Administration, or Support roles
Required Qualifications
Proven hands‐on experience configuring LabWare LIMS (LabWare 8 strongly preferred).
Strong experience with Labware within GMP laboratory operations, particularly:
Raw materials testingCommercial product testingLaboratory equipment workflowsDemonstrated ability to translate regulatory and quality requirements into compliant LIMS configurationsExperience supporting LIMS validation with full requirements traceability.Experience integrating LabWare with:
Instrument systems (e.g., Empower, LabX)· Strong cross‐functional communication skills in regulated environments.
· Preferred Qualifications
· Experience supporting LabWare upgrades or major LIMS implementations.
· Experience working in biopharmaceutical or pharmaceutical GMP environments.
· Experience supporting inspection readiness activities related to LIMS.
· Deliverables & Success Criteria
· Completed on time LabWare LIMS configurations for raw materials, commercial products, and equipment integration.
· Clear requirements‐to‐configuration‐to‐validation traceability
Job Summary
LabWare LIMS Configuration Specialist to support the LabWare 8 upgrade for a US‐based GMP laboratory site. This role will lead a dedicated workstream focused on implementing raw material and commercial product workflows, completing master data configuration, and finalizing integration with laboratory equipment and enterprise GMP systems.
The successful candidate will translate regulatory, quality, and operational requirements into standardized, compliant LabWare LIMS designs and ensure stable execution of configured workflows in a regulated manufacturing environment.
Key Responsibilities
Workstream Leadership & Scope Definition
Support a dedicated workstream supporting implementation of raw material and commercial product processes within LabWare LIMS 8.
· Define and manage LabWare build across:
· Raw materials and commercial product master data
· Test workflows
· Laboratory equipment and interfaces
LabWare LIMS Configuration
Configure raw materials, commercial products including stability, and laboratory equipment in LabWare LIMS using standardized, compliant design patterns.
Ensure LabWare configuration aligns with:
Approved test methodologiesProduct specificationsSampling plansApply controlled build practices and normalized templates to ensure consistency, scalability, and compliance.
Requirements Traceability & Validation Support
Translate regulatory, quality, and operational requirements into standardized LabWare LIMS designs.
Support validation activities by providing clear documentation and traceability for configured LabWare objects following internal procedures.
Instrument & System Integration
Configure and support instrument interfaces between LabWare 8 and a variety of laboratory systems.
May develop or support parsing scripts, where required and permitted by standards and governance.
Support connectivity and data flow between LabWare and other GMP systems, such as LabX
Operational Readiness & Execution
Support stable execution of raw material and equipment workflows in live operations.
Troubleshoot configuration and integration issues impacting laboratory execution.
Partner with site teams to ensure LabWare configurations are fit for intended use and operationally sustainable.
· .
· Stable, compliant execution of configured workflows in operations.
· Successful integration between LabWare and laboratory instruments
· Additional Notes
· This role requires close collaboration with Quality, Validation, IT, and Laboratory teams.
· Work must follow change control, validation, and data integrity requirements.
· Onsite presence may be required based on project phase and site needs.
Company Descriptionwww.techdataservice.comCompany Descriptionwww.techdataservice.com Read LessPay: $87.00 - $107.00 per hour
Job description:
Contract: 7 Months (Renewable)
Job ID: 10171
Location: Onsite - Newbury Park (Thousand Oaks) CA
100% ONSITE Role Strong hands-on experience with LabWare 8 configuration or technical development
Experience in configuring Raw Material Workflows in Labware or Instrument/Equipment integration (Empower/LabX to Labware) preferredExperience with previous LabWare versions is not acceptable, as they differ from LabWare 8Not seeking candidates whose experience is limited to Business Analyst, Project Management, Administration, or Support roles
Required Qualifications
Proven hands‐on experience configuring LabWare LIMS (LabWare 8 strongly preferred).
Strong experience with Labware within GMP laboratory operations, particularly:
Raw materials testingCommercial product testingLaboratory equipment workflowsDemonstrated ability to translate regulatory and quality requirements into compliant LIMS configurationsExperience supporting LIMS validation with full requirements traceability.Experience integrating LabWare with:
Instrument systems (e.g., Empower, LabX)· Strong cross‐functional communication skills in regulated environments.
· Preferred Qualifications
· Experience supporting LabWare upgrades or major LIMS implementations.
· Experience working in biopharmaceutical or pharmaceutical GMP environments.
· Experience supporting inspection readiness activities related to LIMS.
· Deliverables & Success Criteria
· Completed on time LabWare LIMS configurations for raw materials, commercial products, and equipment integration.
· Clear requirements‐to‐configuration‐to‐validation traceability
Job Summary
LabWare LIMS Configuration Specialist to support the LabWare 8 upgrade for a US‐based GMP laboratory site. This role will lead a dedicated workstream focused on implementing raw material and commercial product workflows, completing master data configuration, and finalizing integration with laboratory equipment and enterprise GMP systems.
The successful candidate will translate regulatory, quality, and operational requirements into standardized, compliant LabWare LIMS designs and ensure stable execution of configured workflows in a regulated manufacturing environment.
Key Responsibilities
Workstream Leadership & Scope Definition
Support a dedicated workstream supporting implementation of raw material and commercial product processes within LabWare LIMS 8.
· Define and manage LabWare build across:
· Raw materials and commercial product master data
· Test workflows
· Laboratory equipment and interfaces
LabWare LIMS Configuration
Configure raw materials, commercial products including stability, and laboratory equipment in LabWare LIMS using standardized, compliant design patterns.
Ensure LabWare configuration aligns with:
Approved test methodologiesProduct specificationsSampling plansApply controlled build practices and normalized templates to ensure consistency, scalability, and compliance.
Requirements Traceability & Validation Support
Translate regulatory, quality, and operational requirements into standardized LabWare LIMS designs.
Support validation activities by providing clear documentation and traceability for configured LabWare objects following internal procedures.
Instrument & System Integration
Configure and support instrument interfaces between LabWare 8 and a variety of laboratory systems.
May develop or support parsing scripts, where required and permitted by standards and governance.
Support connectivity and data flow between LabWare and other GMP systems, such as LabX
Operational Readiness & Execution
Support stable execution of raw material and equipment workflows in live operations.
Troubleshoot configuration and integration issues impacting laboratory execution.
Partner with site teams to ensure LabWare configurations are fit for intended use and operationally sustainable.
· .
· Stable, compliant execution of configured workflows in operations.
· Successful integration between LabWare and laboratory instruments
· Additional Notes
· This role requires close collaboration with Quality, Validation, IT, and Laboratory teams.
· Work must follow change control, validation, and data integrity requirements.
· Onsite presence may be required based on project phase and site needs.
Company Descriptionwww.techdataservice.comCompany Descriptionwww.techdataservice.com Read LessThe main function of a clinical research specialist is to perform study start-up and conduct activities including ICF review that meets regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities.
Key Responsibilities:
• Perform study start-up and conduct activities including ICF review that meets regulatory requirements, creating study specific essential document lists, managing and communicating the status of study progress and activities • Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases
• Identify and investigate discrepancies in study documentation by applying clinical protocol and GCP knowledge and develop processes to mitigate reoccurrence throughout study phases
• Conduct in-house and site (if applicable) reviews of associated documentation and participate in internal and competent authority (e.g., FDA, DEKRA, PMDA) audits to ensure all essential clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, Edwards internal SOPs, and US and OUS regulations
• Assess current processes, identify opportunities and propose solutions to improve process efficiency within and across related functional areas
• Partner with cross-functional team (e.g., clinical data management, field teams) with query management, data reviews and resolution
Additional Skills:
• Clinical background, familiar with clinical study process, monitoring, GCP and clinical study relevant regulations.
• High compliance requirements and understand that rights and well-being of human subjects should be protected during clinical study
Education and Experience:
• Bachelor's Degree or equivalent in related field
• 2-4 years of experience required
Company Descriptionwww.techdataservice.comCompany Descriptionwww.techdataservice.com Read Less