Job Description

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.

Oversee and manage with the CRO Project Manager the study conduct in order to ensure adequate and timely delivery of study data and documentation in Trial Master File (TMF):

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)