Clinical Trial Operations Manager, US - Switzerland
- The Clinical Trial Operations Manager will be responsible for the management of US clinical trial(s) activities for our company’s studies, under the supervision of a Clinical Study Director and working closely with the Clinical Trial and Operations Manager in Switzerland.
- This involves oversight of the CRO activities, site and Investigator relationships.
KEY TASKS & RESPONSIBILITIES
- Manage 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).
- Participate in site identification, evaluation, contracting, initiation, monitoring and close out visits including visiting sites.
- Communicate with clinical site staff, investigators and CROs as appropriate to ensure optimal Sponsor-site relationships.
- Monitor the timely progress of clinical studies.
- Proactively manage recruitment timelines - suggest and implement recruitment strategies to meet study timelines and company objectives.
- Proactively identify potential study risks/ problems and manage them in close collaboration with cross-functional teams.
- Prepare, on a regular basis, updates on study progress and tracking for the Company Management and appropriate Boards or Committees.
- Participate the selection and contracting of clinical service providers.
- Prepare or review and approve study materials such as CRFs, patient diaries, drug accountability forms, study and investigator manuals, monitoring plans, and monitoring reports.
- Assist in set-up and management of CTS.
- 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.
- Assist in planning and managing investigator meetings, other trial specific meetings, KOL meetings.
- Manage 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 for the payment process of external invoices and track payment of contracts related to project.
PROFESSIONAL SKILLS & EXPERIENCE
- Minimum 4 years’ experience managing multisite clinical phase 2–4 studies.
- 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.
- Good knowledge of ICH/GCP and local regulations in the US.
- Good knowledge of Word, PowerPoint, Excel, Outlook.
PERSONAL SKILLS & COMPETENCIES
- Strong team player and ability to work in functional matrix organization.
- Excellent 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 through-out the US and occasionally to Europe.
- Appropriate scientific or medical degree (e.g, Biology, Pharmacy, Clinical Research).
- Complete fluency in English.