Senior Clinical Trial Manager

Abbott; Mumbai City; On-site; INR 900,000 - 1,400,000; Full time

Job summary

Abbott in Mumbai, India is seeking a Clinical Trials Start-Up Lead to plan and supervise start-up activities across disciplines, coordinating CROs and vendors to meet safety, timelines and quality objectives.

The role requires collaboration with internal study teams, external partners, and regulatory/compliance processes, including preparation of core documents and strategy reviews. This is a on-site position at the Mumbai Development Center.

Qualifications

• Plan, coordinate and oversee all start-up activities of internal disciplines (Drug supply, Regulatory, Safety, Data Management etc.) and being the main contact for involved CROs and other external vendors.
• 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 procedures (e.g. BIOM, Task List).
• Read, review and assist in preparation of core project documents (e.g. Investigator Brochure, Concise Clinical Development Plan, Protocol, Informed Consent Form).
• Review key Clinical Trial Management strategies like: Communication plan / Feasibility / Patient & Site recruitment / Drug supply / EC&RA Submission.

Responsibilities

• Oversee and manage with the CRO Project Manager the study conduct to ensure timely delivery of study data and documentation in Trial Master File (TMF).
• Use tools to monitor status of patient recruitment and take corrective action if necessary.
• Ensure respect of agreed deliverables, timelines, milestones, budget, quality.
• Co-coordinate timely availability of all supplies important for the conduction of trials, including site re-supply.
• Monitor data collection, cleaning and data transfer for completeness and quality.
• Review audit reports and ensure issues are resolved.
• Participate in strategic decision making to improve recruitment.
• Support activities to generate study report/dossier.
• Supervise and monitor the transfer and archiving of the clinical file (TMF).

Job description

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

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)