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

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Agree and/or ensure implementation of study principles and deliverables (safety, timelines, quality, milestones, budget, etc.) and follow-up to guarantee adherence

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Facilitate communication and ensure adequate collaboration between all involved parties

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Communicate effectively processes to in-/external service groups and clients in accordance with all applicable procedures (e.g. BIOM, Task List etc.)

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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

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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

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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):

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Use efficiently tools to monitor status of e.g. patient recruitment and take corrective action if necessary

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Ensure respect of agreed deliverables, and communicate efficiently within the teams (timelines, milestones, budget, quality)

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Co-coordinate timely availability of all supplies important for the conduction of trials, including the re-supply of sites

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Monitor data collection, cleaning and data transfer with respect to completeness, quality and timely delivery of the final results

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Review audit reports and ensure issues are resolved

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Participate in strategic decision making to improve recruitment

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Apply operational risk management plan (if applicable)

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Support activities to generate study report / dossier

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Supervise and monitor the transfer and archiving of the clinical file (e.g. TMF)