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Syneos Health inVentiv Health Commercial LLC
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  • Clinical Project Manager - Oncology (Client Dedicated/Remote)Syneos He... Read More
    Clinical Project Manager - Oncology (Client Dedicated/Remote)Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.Discover what our 29,000 employees, across 110 countries already know:WORK HERE MATTERS EVERYWHEREWhy Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.Job ResponsibilitiesCLINICAL PROJECT MANAGER II - ONCOLOGYSponsor Dedicated - Remote - United StatesAre you passionate about advancing cancer research and bringing innovative therapies to patients worldwide? We are seeking experienced Clinical Project Managers with strong global oncology clinical trial experience to join a high-performing sponsor-dedicated team supporting a diverse portfolio of oncology studies across multiple indications and phases of development.This is a fully remote, US-based opportunity where you will play a critical role in the operational leadership and execution of global clinical trials. We are specifically seeking professionals with 3+ years of hands-on Clinical Project Management experience leading global oncology studies and collaborating with cross-functional teams, vendors, and international stakeholders.WHAT YOU'LL DOAs a Clinical Project Manager II, you will help drive the operational execution and delivery of global oncology clinical trials, ensuring studies are conducted efficiently, compliantly, and according to established timelines.Key Responsibilities Support and partner with Clinical Study Leads and cross-functional study teams on global oncology trials Lead day-to-day study management activities across study startup, conduct, maintenance, and closeout Manage study timelines, deliverables, risks, and issue resolution Oversee external vendors, CROs, central laboratories, imaging vendors, and specialty providers Coordinate Clinical Trial Team (CTT) meetings and drive action item follow-up Support study-level planning, forecasting, and operational strategy execution Monitor study performance metrics and proactively identify areas requiring intervention Ensure inspection readiness and compliance with applicable regulations and sponsor requirements Collaborate with stakeholders across Clinical Operations, Data Management, Biostatistics, Medical Monitoring, Regulatory Affairs, Safety, Supply Chain, and Quality Contribute to study status reporting and executive-level communications Support achievement of study milestones, enrollment targets, database locks, and study closeout activitiesWHAT YOU WILL BRINGRequired Qualifications Bachelor's degree in a scientific, healthcare, or related field is required 3+ years of Clinical Project Management experience supporting global oncology clinical trials Experience managing studies across multiple countries and regions (North America, Europe, Asia-Pacific, Latin America, or other global regions) Vendor management experience required Strong understanding of clinical trial operations and study lifecycle management Experience supporting Phase I, Phase II, Phase III, and/or Phase IV oncology studies Strong working knowledge of ICH-GCP guidelines and clinical research regulations Proficiency with Microsoft Office Suite Ability to work effectively within global, cross-functional matrix organizationsONCOLOGY THERAPEUTIC AREA EXPERIENCECandidates should have direct clinical trial experience supporting one or more oncology indications: Lung cancer (NSCLC, SCLC) Melanoma Renal cell carcinoma (kidney) Bladder cancer Head & neck squamous cell carcinoma Triple-negative breast cancer Cervical cancer Gastric and gastroesophageal cancers Esophageal cancer Hepatocellular carcinoma (liver) Endometrial cancer Ovarian cancer Colorectal cancer Biliary tract cancer Prostate cancer Urothelial carcinoma Hematologic malignancies (multiple myeloma, lymphoma, leukemia) Antibody-drug conjugates (ADCs) Personalized cancer vaccines KRAS inhibitors T-cell engagers Cell-directed immunotherapies Candidates should be prepared to discuss the indications supported, study phases, geographic scope, and their specific responsibilities on each program.PREFERRED QUALIFICATIONS Experience independently leading global oncology studies Experience supporting complex, multi-regional Phase II and Phase III programs Experience with early-phase oncology studies (Phase I/Ib) Experience with immuno-oncology, targeted therapies, cell therapy, or hematologic malignancies Familiarity with CTMS, eTMF, IRT/RTSM, and clinical data review platforms Experience working in sponsor-dedicated or FSP environmentsKEY SKILLS & COMPETENCIES Strong project management and organizational skills Excellent communication and stakeholder management abilities Proven ability to manage multiple priorities in a fast-paced environment Strong risk identification and mitigation capabilities Detail-oriented with a focus on quality, compliance, and execution Strong collaboration skills across global teams and functions Ability to influence without direct authority and drive accountability across study teamsCLINICAL PHASE EXPERIENCEWe welcome candidates with experience supporting: Phase I / First-in-Human Studies Phase I/Ib Dose Escalation Studies Phase II Proof-of-Concept Studies Phase II/III Registrational Studies Phase III Global Pivotal Trials Phase IV and Post-Marketing StudiesExperience supporting global, multi-country oncology programs through multiple phases of development is highly preferred.WHY JOIN US? Work on innovative oncology programs advancing new treatment options for cancer patients worldwide Support cutting-edge therapies across solid tumors, hematologic malignancies, immuno-oncology, and cell and gene therapy Join a collaborative, sponsor-dedicated team focused on operational excellence Enjoy the flexibility of a fully remote US-based role Expand your impact across global clinical development programs and contribute to bringing life-changing therapies to patientsIf you are an experienced Oncology Clinical Project Manager with 3+ years of global clinical trial management experience and a passion for advancing cancer research, we would love to hear from you.Salary Range $120,000-135,000We are always excited to connect with great talent. This posting is intended for a possible upcoming opportunity rather than a live role. By expressing your interest, you'll be added to our talent pipeline and considered should this role become available.At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.Salary Range:The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.Get to know Syneos HealthOver the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.Additional InformationTasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills . click apply for full job details Read Less
  • Why Syneos Health Syneos Health is a leading fully integrated biopharm... Read More
    Why Syneos Health Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes. Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assess factors that might affect subject/patient's safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues. Per the Clinical Monitoring/Site Management Plan (CMP/SMP): Assesses site processes. Conducts Source Document Review of appropriate site source documents and medical records. Verifies required clinical data entered in the case report form (CRF) is accurate and complete. Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines. Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture. Verifies site compliance with electronic data capture requirements. May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations. Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt to changing priorities to achieve goals / targets. May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate. Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required. For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II. Additional responsibilities include:Site support throughout the study lifecycle from site identification through close-out. Knowledge of local requirements for real world late phase study designs.Chart abstraction activities and data collection Collaboration with Sponsor affiliates, medical science liaisons and local country staff. The SMA II may be requested to train junior staff. Identify and communicate out of scope activities to Lead CRA/Project Manager. Proactively suggest potential sites based on local knowledge of treatment patterns, patient advocacy and Health Care Provider (HCP) associations. Qualifications Bachelor's degree or RN in a related field or equivalent combination of education, training and experience Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements Must demonstrate good computer skills and be able to embrace new technologies Excellent communication, presentation and interpersonal skills Ability to manage required travel of up to 30% on a regular basis US ONLY: As part of your employment with Syneos Health, you may be deployed to Sites that require certain medical and other personal information to gain facility access. Pursuant to our Employee Privacy Notice, Syneos Health can provide the Sites with the information necessary for you to gain such access. Further, a Site may ask you for additional information beyond that which Syneos Health has in its possession. You are required to comply with any such Site requests as a condition of your employment with Syneos Health. Please note that failure to provide requested information may result in a Site barring you from entry, which could put your ongoing employment at risk. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. company car or car allowance Health benefits to include Medical, Dental and Vision Company match 401k eligibility to participate in Employee Stock Purchase Plan Eligibility to earn commissions/bonus based on company and individual performance flexible paid time off (PTO) and sick time Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. http://www.syneoshealth.com Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. #J-18808-Ljbffr Read Less

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