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.
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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 key 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
• P
📌 Senior Clinical Trial Manager (Mumbai)
🏢 Abbott
📍 Mumbai