About this role
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) The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.
JOB FAMILY: Clinical Affairs / Statistics DIVISION: EPD Established Pharma LOCATION: India > Mumbai : Mumbai Development Center - EPD ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)