Associate Clinical Trial Manager
- Experience Level
Our client who is a fully integrated biopharmaceutical solutions organization is currently seeking an Associate Clinical Trial Manager to join the team on a contract basis. They're looking for enthusiastic and talented individuals who thrive on challenge and change, and who want to make a difference through the delivery of results. I've provided further information on the role below:
Location: Uxbridge, United Kingdom
FTE: Full - Time
- 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 or 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 Clinical Contracts and Finance (CCF) 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, CCF, Materials and Logistics (M&L), and Drug Safety and Public Health (DSPH) 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.
- Performs administrative duties in a timely manner as assigned.
- Provides administrative assistance in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
- May monitors fairly routine study sites, performing routine data collection, source data verification, and review of routine regulatory documents/files in compliance with protocol, regulatory requirements, SOPs, and Monitoring Plan, as required.
- 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.
- May assist in compilation of investigator brochures under close supervision.
- Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
- Travel might be required.
Requirements / Skills and Experience
- 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.
- Must be able to participate in departmental or interdepartmental strategic initiative under general supervision.
- Must be able to contribute to SOP development.
About us Planet Pharma is an American parented Employment Business/Agency that provides global staffing services with its head-quarters in Chicago and our EMEA regional office located in Central London. We have invested significantly in creating a robust international platform that enables us to work compliantly in 30+ countries with a current network of 2500+ active contractors globally as well as a very strong permanent / direct hire recruitment offering. Our specialist knowledge and close relationships with our clients and the wider industry really makes us unique in our field. Just recently we were recognised by FORBES as the 17th best professional staffing firm, and have won multiple awards from industry accredited bodies for our commitment to excellence and service delivery. We have extensive functional expertise including: Regulatory Affairs, Pharmacovigilance, QA, QC, Submissions experts, Clinical development, Quality, Biostatistics, and Medical Affairs / Writing. We are an equal opportunities Recruitment Business and Agency. We welcome applications from all suitably qualified candidates regardless of their race, sex, disability, religion/belief, sexual orientation or age.