Senior Clinical Trial Manager

Abbott; Maharashtra; On-site; INR 1,800,000 - 3,200,000; Full time

Job summary

Abbott India is seeking a Clinical Start-Up Lead to plan, coordinate and oversee all start-up activities across drug supply, regulatory and safety domains. You will supervise CROs and external vendors, ensure adherence to timelines, budget and quality, and facilitate cross-functional collaboration with trial teams.

Responsibilities include maintaining study documents, managing recruitment strategies, and ensuring smooth communication with in-house and external partners.

Responsibilities

• Plan, coordinate and oversee all start-up activities of internal disciplines and supervise CROs/external vendors.
• Agree and implement study principles, deliverables, timelines, budget and quality.
• Facilitate communication and collaboration between all involved parties.
• Communicate processes to in-/external service groups and clients per procedures.
• Participate in trial-related teams and organize external meetings (Kick-off, CRA meeting, Investigator meeting).
• Read, review and assist in preparation of core project documents (Investigator Brochure, Concise Clinical Development Plan, Protocol, Informed Consent Form).
• Review key Clinical Trial Management strategies (communication plan, feasibility, recruitment, drug supply, EC/RA submission).
• Monitor recruitment status and take corrective action if necessary.
• Ensure deliverables, timelines, milestones, budget and quality are met.
• Co-coordinate availability of supplies for trials and resupply to sites.
• Monitor data collection, cleaning and transfer for quality and timely results.
• Review audit reports and resolve issues.
• Participate in strategic decisions to improve recruitment.
• Apply operational risk management plan if applicable.
• Support activities to generate study reports/dossier.
• Supervise transfer and archiving of the clinical file (TMF).

Job description

Responsibilities

• 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.
• 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)