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 applicableAgree and/or ensure implementation of study principles and deliverables (safety, timelines, quality, milestones, budget, etc.) and follow-up to guarantee adherenceFacilitate communication and ensure adequate collaboration between all involved partiesCommunicate 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 applicableRead, review and/or assist in preparation of core project documents (e.G. Investigator Brochure, Concise Clinical Development Plan, Protocol, Informed Consent Form) as applicableReview 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 necessaryEnsure respect of agreed deliverables, and communicate efficiently within the teams (timelines, milestones, budget, quality)Co-coordinate timely availability of all supplies significant for the conduction of trials, including the re-supply of sitesMonitor data collection, cleaning and data transfer with respect to completeness, quality and timely delivery of the final resultsReview audit reports and ensure issues are resolvedParticipate in strategic decision making to improve recruitmentApply operational risk management plan (if applicable)Support activities to generate study report / dossierSupervise and monitor the transfer and archiving of the clinical file (e.G. TMF)

📌 Senior Clinical Trial Manager (Maharashtra)
🏢 Abbott
📍 Maharashtra