Clinical Trial Manager/Director, maternity leave replacement - Switzerland
- The Clinical Trial Manager/Director, maternity leave replacement, will be responsible for the management of clinical trial(s), set-up and performance.
- This is an operational role.
KEY TASKS & RESPONSIBILITIES
- Define study planning including timelines projections and budget forecasting.
- Track study activities in accordance with the approved study plan, timelines and budget.
- Participate in site identification, evaluation, initiation, monitoring and close out visits as necessary.
- Manage communication and coordinate clinical trial activities with clinical service providers (Clinical Operations, Data management, central laboratory etc.) and clinical sites (Investigators, research staff, pharmacists, laboratory staff, ethics committees).
- Monitor the timely progress of clinical studies.
- Proactively manage recruitment timelines - suggest and implement recruitment strategies to meet study timelines and company objectives.
- Communicate with clinical site staff, investigators and CROs as appropriate to ensure optimal Sponsor-site relationships.
- Proactively identify potential study risks/ problems and manage them in close collaboration with cross-functional teams.
- Review monitoring visit reports and suggest improvement to potential issues.
- Contribute to monitoring sites’ compliance with ICH/GCP guidelines.
- Prepare/review clinical documents for communication or submission to regulatory authorities and ethics committees.
- Review and approve study materials such as CRFs, patient diaries, drug accountability forms, study and investigator manuals, monitoring plans, and monitoring reports.
- Develop and maintain a competent knowledge of applicable Policies, Guidelines, Standard Operating Procedures (SOPs), conventions, tools, templates and instructions, including current Good Clinical Practice (GCP) and applicable local regulations relating to the conduct of clinical trials.
- Review legal agreements.
- Supervise the setup, the organization and maintenance of clinical study documentation (Main Study Files, etc.) including final reconciliation, QC and archival of Clinical Trial Master File.
- Collaborate with the help of the Clinical Trial Assistant, Finance Controller and the Fiduciary for the payment process of external invoices and track payment of contracts related to project.
- Supervise external archiving with the help of the CTA as per Company SOPs.
- Prepare, on a regular basis, updates on study progress and tracking for the Company Management and appropriate Boards or Committees.
PROFESSIONAL SKILLS & EXPERIENCE
- Minimum 5 years’ experience in management of multi-national clinical phase 2–4 studies for a Clinical Research Organization (CRO) or a pharmaceutical company.
- Experience in coordinating and/or supporting the management of site-related activities, development of tracking tools, dealing with clinical sub-contractors (central laboratory, clinical and data management etc.) and ability to manage recruitment timelines by appropriate strategies.
- Good understanding of the roles and responsibilities of all relevant functions involved in a clinical trial.
- Ability to interface with Finance and manage the budget.
- Good knowledge of ICH/GCP and local regulations in EU.
- Demonstrated project management skills.
- Good knowledge of Word, PowerPoint, Excel, Outlook.
PERSONAL SKILLS & COMPETENCIES
- Strong team player and ability to work in functional matrix organization.
- Good communication, negotiation and interpersonal skills.
- Organized, rigorous, reliable, rapid and precise.
- Self-motivated, pro-active and high sense of initiative.
- Strong ethics and creativity.
- Flexible, mature and able to work under pressure.
- Willing and able to travel globally.
- Willing to learn new areas of expertise as required for the position.
- Appropriate scientific or medical degree (e.g, Biology, Pharmacy, Clinical Research)
- Complete fluency in English is a must. French is a plus