Senior Clinical Study Management Associate
Are you looking to establish your Clinical career?
A pharmaceutical company in search of a Senior Clinical Trial Manager Associate to join on a 12 month contract, with the possibility of extension. This candidate will join the Late Phase Clinical Operations in London.
- Serves as the key operational contact with external investigators and internal stakeholders.
- Evaluates scientific proposals or protocols to identify logistical, regulatory and safety elements and implications.
- Manages assigned studies by establishing strong partnerships with external investigators and collaborators to ensure CO and ISR Agreements for financial product support are processed in a timely manner and to a high quality
- Proactively identifies operational challenges and in collaboration with senior team members provides and implements solutions to ensure studies remain on track.
- Maintains efficient collaboration with company's Development Business Operations team and external investigator/study representative to ensure contracts are executed in a timely manner.
- Supports study drug planning and shipping activities with Materials & Logistics.
- Communicates and collaborates with other functional groups including but not limited to Medical Affairs, Regulatory Affairs, Development Business Operations, Materials and Logistics (M&L), and Global Patient Safety to ensure efficient management of study activities.
- Forecasts, tracks and reports CO and ISR milestones, as well as verifies completeness of the study milestones prior to invoice payment.
- Provides monthly study updates to the appropriate internal stakeholders.
- Ensures all budget or drug supply modifications are appropriately approved, documented and tracked.
- Implements working processes to promote high quality, efficient, and compliant systems for Late Phase research management.
- * Supports and implements Clinical Operations Quality Initiatives.
- Maintains internal Clinical Operations and Medical Affairs databases and clinical study data and document repositories.
- Provides administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
- Under supervision may assist in development and review of protocols, informed consents, and case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports.
- Under supervision may have country/site oversight for ensuring timely start-up, vendor oversight of monitoring activities and data quality review.
- Assists in preparation of progress reports, interim and final study reports, including resolving data discrepancies.
Skills and Requirements
- Typically requires a BSc in a relevant scientific discipline and relevant clinical experience in the pharmaceutical or health care industry or equivalent.
- Excellent planning, time management, organizational, and administrative skills.
- Demonstrates core values of strong team work and accountability with ability to prioritize competing timelines and deliver excellent results.
- Learning ability with demonstrated flexibility required to maintain a fast pace.
- Excellent verbal, written, interpersonal and presentation skills are required.
- Tenacity and perseverance to ensure a high level of customer service.
- Able to maintain internal/external networking and cross-functional collaboration.
- Demonstrates a high sense of urgency and commitment to excellence in the successful execution of deliverables.
- Must be able to prioritize multiple tasks, and accomplish goals using well-defined instructions and procedures.
- Good knowledge and understanding of ICH GCP, FDA and EMEA regulations and guidelines applicable to post-authorization studies.
- Must be proficient with MS Word, PowerPoint, Outlook, and Excel.
- Must be familiar with routine medical/scientific terminology.
- Able to participate in departmental or interdepartmental strategic initiative under general supervision.
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