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Form of workJob Description
Overview:
Tekwissen group, is a workforce management provider throughout the USA and many other countries in the world. This client is a German multinational Pharmaceutical and biotechnology company and one of the largest pharmaceutical companies in the world, headquartered in Leverkusen, and areas of business include pharmaceuticals; consumer healthcare products, agricultural chemicals, seeds and biotechnology products.
Job Title: Study Manager (Mid)-Clinical Dev. & Ops-R&D-PH
Location: Whippany NJ 07981
Duration: 6 Months
Job Type: Contract
Work Type: Hybrid
DEPARTMENT/TEAM DESCRIPTION
- Operational Excellence and Project Management in Global Medical Affairs (GMA), Oncology SBU is a global function which partners and collaborates with the MA Teams and Key Stakeholders (internal and external) to assist in achieving short and long term strategic goals while adhering to "LIFE" values (leadership, integrity, flexibility, efficiency).
POSITION SUMMARY
- The Senior Contract Operations Excellence & PM Manager position is accountable for compliant and high quality management of GMA company-sponsored studies (both non and interventional), Investigator Initiated Research (IIR) and Investigator-Sponsored Collaborative Studies (ISCS) data acquisition projects, and Expanded Access Programs (EAPs)
POSITION DUTIES & RESPONSIBILITIES
- Lead all aspects of clinical studies from planning to execution.
- Assigned studies include interventional, non-interventional and data acquisitions within Global Medical Affairs Oncology SBU
- Overall accountable for study management of assigned studies, serve as primary contact for CRO.
- Lead and manage client multi-disciplinary cross functional team in all aspects of studies activities including but not limited to site start up, CRO/vendor selection and management, study-specific timelines and study execution
- Coordinate for fair market value assessment of study budgets; initiate and manage, and support contracting process for vendor and study sites.
- Liaise with appropriate client internal protocol review committees to ensure timely review, response and finalization of the protocol and protocol amendment
- IIR and/or ISCS data acquisition projects.
- Responsibilities include chair conference calls, coordinate between client team and IIR/ISCS sponsors on activities such as data review, query resolution and independent review of imaging scans, when applicable.
- Develop and manage overall project timelines
- Support GMA Medical Leads on overall delivery of the data generated from Oncology Non-Interventional Studies (NIS).
- Responsibilities include, but not limited to, monitor country/site selection and activation process, contribute in CRF design and review, study budget management, support Medical Leads on clinical data consistency review to ensure that data issues raised during medical and DM data review are adequately queried and resolved
- Manage study drug forecasting.
- Liaise with Clinical Supplies Management to ensure drug supply planning, labeling and distribution are executed timely and within applicable country and regional guidelines
- Assist and/or lead in executing Expanded Access Programs within Oncology MA.
- Responsibilities include collaborate with country affiliates and Medical Experts as appropriate to ensure timely alignment and execution of country specific processes including permit license application, commercial product transition plan, and Real World Data (RWD) data generation when applicable
REQUIREMENTS/PREFERENCES
Education Requirement(s):
- Bachelor's degree required; life science preferred
- Masters in Science or Business Administration preferred
Skill & Competency Requirements:
- Extensive (7+ years) study management experience involving Phases 2 & 3 studies from planning through regulatory submission; regulatory submission experience a plus
- Understanding of the connection between protocol endpoints, study design, CRF design and data collection; clinical science backyard a plus
- At least 5 years Oncology experience (can be outside of industry)
- Strong written, organizational, and computer (e.g. Excel, power point) skills
- Excellent interpersonal and communication skills as candidate will interact with client cross functional team members as well as liaise with external academic networks and cooperative groups from all over the global
TekWissen Group is an equal opportunity employer supporting workforce diversity.
