Senior Clinical Trial Manager

Thornton Tomasetti; Mumbai; On-site; INR 1,200,000 - 2,400,000; Full time

Job summary

Abbott India seeks a qualified professional to plan, coordinate and oversee all start-up activities across internal disciplines such as Drug supply, Regulatory, Safety, and Data Management. You will be the main contact for CROs and external vendors, steering deliverables, budgets, timelines, and quality.

The role involves ensuring effective communication between in-house teams and external partners, and supporting trial-related meetings and TMF management.

Qualifications

• Experience planning, coordinating and overseeing start-up activities.
• Ability to manage CROs and external vendors and ensure deliverables.
• Proven oversight of safety, timelines, quality, milestones and budget.

Responsibilities

• Read/review core trial documents and assist in preparation as applicable.
• Oversee trial conduct with CRO PM to ensure timely data delivery.
• Coordinate supplies and TMF activities for trial sites.

Skills

Start-up management

CRO coordination

Regulatory oversight

Data management

TMF familiarity

Tools

TMF systems

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

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)

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, and for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.

We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.