Associate Clinical Project Manager job in Paramus
|Employer:|| Glenmark Pharmaceuticals Inc., USA|
|Category:||Research and Development|
|State:||New Jersey (NJ)|
Position Summary :
The Associate Clinical Project Manager (ACPM) is responsible for the sponsor oversight activities of all aspects of global clinical studies and supporting the operational execution of study deliverables, in collaboration with the Clinical Project Manager (CPM) and the Clinical Project Team, on time, within budget, and with quality.
Contribute to the management of clinical research organizations (CROs) or other trial vendors by monitoring performance metrics, issue escalation and corrective actions, and implementation of enrollment and recruitment strategies. The Associate CPM will also support the development of study-specific tools for clinical Sites' and CRA use, review trip reports, and support other objectives for the Clinical Project Team, as needed. Serve as deputy for the CPM (when appropriate).
The ACPM will also contribute, as appropriate, to process improvement and knowledge-sharing within GCRO.
Key Responsibilities :
- Contribute to the monitoring oversight process, including but not limited to: creating and implementing the Sponsor Monitoring Oversight Plan for assigned trials to oversee clinical monitoring progress and to ensure CRO performance meets quality standards and team expectations. Also responsible for managing Site and monitoring issue prevention, escalation, and corrective actions, reviewing monitoring visit reports for trends and/or compliance issues, proactively ensuring project teams are aware of all monitoring metrics and critical issues, and conducting Sponsor Oversight Visits (SOV) to selected study sites.
Clinical Study Oversight and Management:
- Support the development of study documents, including but not limited to: draft model/master ICF, clinical protocol, feasibility questionnaires, case report forms (CRF), CRF completion guidelines, Site/CRA tools, Investigator Meeting slides, and others as assigned.
- Support the site activation process, including but not limited to: Site/Investigator identification, evaluation and selection, tracking of study start-up metrics, and ensuring that study information are accurately reported within relevant systems and to key stakeholders
- Support the CPM in vendor management activities as appropriate
- Support the CPM in defining and implementing the data review plan for assigned trials, as appropriate, participating in data review activities to support blinded data review meetings (BDRMs) and database locks
- Support the global cross-functional clinical project team, including but not limited to: participating and reporting study progress, issues/actions/resolutions, organizing/chairing study sub-team meetings within scope of delegated responsibilities.
- Other study activities, as assigned
- For assigned vendors for study oversight, support the monitoring of expenditure of funds relative to budgetary targets on an ongoing basis.
- Facilitate efforts to implement appropriate interventions
- Participate in development of department processes and best practices, including review of Standard Operating Procedures (SOPs) and development of standard reports, templates and/or forms, when applicable
- Bachelor's degree or equivalent or any relevant and qualifying training education/background in biological sciences or in healthcare
- At least 3-5 years of clinical research experience (CRO, Pharmaceutical, Biotechnology and/or healthcare setting)
- At least 3 years of site management and field monitoring experience
- Experience as a Lead CRA preferred
- Flexibility in work hours; Travel required approximately 25%
- Demonstrated capabilities in supporting operational aspects of clinical study activities
- Knowledge of ICH Good Clinical Practice, and up-to-date knowledge of legislation and regulations as relates to clinical research
- Experience in Phase I - III in various therapeutic areas
- Leadership / Managerial Attributes
- Demonstrated capabilities in supporting operational aspects of clinical study activities.
- Excellent communication, organization and tracking skills with involvement in cross-functional, multicultural/international teams
- Advanced attention to detail, with strong critical thinking, problem solving, and analytical capabilities
- Proven ability to work either independently or in a team setting, and to prioritize and organize work to meet set deadlines
- Proficiency in Microsoft Office Products (Word, Excel, and PowerPoint) and other electronic systems (CTMS, EDC, and eTMF)