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Team Lead (Clinical Trial Operations)

Prorelix Research
ProRelix Research
5-8 years
Not Disclosed
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.