A challenging opportunity to join the team based in Madrid Affiliate Office, as a Clinical Trial Manager Associate (CTMA), to be responsible for the management of post-authorization studies across different therapeutic areas. Plays a vital role in successful implementation and support of Company's Sponsored, Collaborative (CO) and Investigator-Sponsored Research (ISR) projects.
A research-based bio pharmaceutical company dedicated to deliver life-saving therapies to patients in need. A Company oriented to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
For CO and ISR, with supervision:
- Serves as the key operational contact with external investigators and internal stakeholders.
- Evaluates scientific proposals or protocols to identify logistical, regulatory or contractual 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.
- Supports study drug planning and shipping activities with Materials & Logistics.
- Collaborates with other functional groups including but not limited to Medical Affairs, Regulatory Affairs, Clinical Contract and Finance, Materials and Logistics (M&L), and Pharmacovigilance 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.
- Maintains internal Clinical Operations databases and clinical study data and document repositories.
For Company Sponsored trials, with supervision:
- Assist with the setting and updating of study time lines.
- Provides administrative assistance with site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
- Participate in or manage project meetings and conference calls with CROs, vendors and multi-functional teams.
- May monitor study sites, performing routine data collection, source data verification and review of regulatory documents/files in compliance with protocol, regulatory requirements, SOPs and Monitoring Plans, as required.
- May assist in development and review of protocols, informed consents, case report forms, monitoring plans, abstracts, presentations, manuscripts and clinical study reports.
- Assists in preparation of safety, interim and final study reports, including resolving data discrepancies.
For activities at the Spanish Affiliate:
- Supports the Affiliate by providing updated information about R&D activities in the region.
- Maintains internal Clinical Operations databases and document repositories as supporting information for the PROFARMA dossier.
- Tracks invoices and payments related to R&D expenses.
- 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 time lines 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, GVP, 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.
A challenging opportunity to join the team to be responsible for the management of post-authorization studies across different therapeutic areas with a competitive salary package, in a highly innovative and efficient environment.