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Open nowPosted 12 days ago

Senior Clinical Trial Manager

Abbott3,626 open roles

Where
India > Mumbai : Mumbai Development Center - EPD
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Your applicationOpen nowSenior Clinical Trial ManagerAbbott · India > Mumbai : Mumbai Development Center - EPD

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The clock on this job

Early applications get read.

12.9% of postings close within 7 days. Measured by our own scanner across the market. Abbott postings stay open a median of 5 days.

Share of postings closed within
  1. 2.2%1 day
  2. 4.7%3 days
  3. 12.9%7 days
  4. 21.0%14 days
  5. 35.6%30 days
  6. 58.5%60 days
This job: posted 12 days ago

Abbott median: 5 days open

The posting

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)

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