Senior Clinical Trial Manager

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)