Team Lead (Clinical Trial Operations)

5-8 years

Not Disclosed

Pune

10 Jan. 23, 2025

Job Description

Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Team Lead (Clinical Trial Operations)

Location: Pune, India

Experience Required: 5 – 8 Years

Job Description:

We are looking for an experienced and dynamic Team Lead for Clinical Trial Operations to join our team in Pune. The ideal candidate will have 5 to 8 years of experience in clinical trial management, with a strong understanding of clinical operations and the ability to lead and mentor a team. This role is responsible for overseeing the day-to-day operations of clinical trials, ensuring that they are executed efficiently, within timelines, and in compliance with regulatory guidelines.

Key Responsibilities:

Lead and manage a team of Clinical Research Associates (CRAs) and other clinical trial staff, ensuring smooth and effective trial operations.
Oversee the planning, execution, and close-out of clinical trials, ensuring adherence to study protocols, ICH-GCP, and applicable regulatory requirements.
Develop and manage project timelines, ensuring that all trial activities are completed on schedule and within budget.
Collaborate with internal stakeholders and external partners to ensure effective communication and coordination across all phases of the clinical trial.
Provide guidance and mentorship to team members, fostering their professional development and ensuring high performance.
Conduct regular team meetings to review progress, address issues, and provide strategic direction.
Identify potential risks or obstacles to trial success and implement proactive solutions to mitigate them.
Review and approve key study documents such as monitoring plans, site contracts, and clinical trial reports.
Ensure compliance with all regulatory, ethical, and safety requirements for clinical trials.
Monitor site performance, resolve issues, and maintain strong relationships with study sites and investigators.
Contribute to the preparation and submission of regulatory documents and reports.

Qualifications:

Bachelor’s degree in Life Sciences, Pharmacy, or a related field. Advanced degrees (e.g., Master’s, PhD) are a plus.
5-8 years of experience in clinical trial operations, with at least 2 years in a leadership or managerial role.
Strong knowledge of ICH-GCP, local regulatory guidelines, and clinical trial management processes.
Proven experience in managing clinical trial teams and coordinating large-scale clinical studies.
Excellent leadership, communication, and interpersonal skills.
Strong problem-solving abilities and attention to detail.
Ability to manage multiple projects and prioritize effectively.
Proficient in clinical trial management systems (CTMS), Microsoft Office, and other relevant software tools.
Willingness to travel as needed.

This is an exciting opportunity for a skilled leader in clinical trial operations to contribute to the success of our clinical programs. If you are looking to join a collaborative and fast-paced environment and are passionate about advancing clinical research, we encourage you to apply.

Send your CV at career@prorelixresearch.com to explore career opportunities with ProRelix Research.

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Team Lead (Clinical Trial Operations)

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