Senior Clinical Trial Manager

• Plan coordinate and oversee all start-up activities of internal disciplines (Drug supply Regulatory Safety Data Management etc.) and being the main contact (supervise steer etc.) for involved CROs and other external vendors if applicable
• Agree and/or ensure implementation of study principles and deliverables (safety timelines quality milestones budget etc.) and follow-up to guarantee adherence
• Facilitate communication and ensure adequate collaboration between all involved parties
• Communicate effectively processes to in-/external service groups and clients in accordance with all applicable procedures (e.g. BIOM Task List etc.)
• Participate in teams related to trial conduct (e.g. Clinical Study team Extended Joint Abbott- CRO Clinical Team Drug supply team etc.) and organize/attend external key study meetings (Kick-off meeting CRA meeting Investigator meeting etc) as applicable
• Read review and/or assist in preparation of core project documents (e.g. Investigator Brochure Concise Clinical Development Plan Protocol Informed Consent Form) as applicable
• Review key Clinical Trial Management strategies like: Communication plan / Feasibility / Patient & Site recruitment / Drug supply / EC&RA Submission etc.

• Use efficiently tools to monitor status of e.g. patient recruitment and take corrective action if necessary
• Ensure respect of agreed deliverables and communicate efficiently within the teams (timelines milestones budget quality)
• Co-coordinate timely availability of all supplies important for the conduction of trials including the re-supply of sites
• Monitor data collection cleaning and data transfer with respect to completeness quality and timely delivery of the final results
• Review audit reports and ensure issues are resolved
• Participate in strategic decision making to improve recruitment
• Apply operational risk management plan (if applicable)
• Support activities to generate study report / dossier
• Supervise and monitor the transfer and archiving of the clinical file (e.g. TMF)

The base pay for this position is

In specific locations the pay range may vary from the range posted.