Team Lead (Clinical Trial Operations)

5-8 years

Not Disclosed

India Pune

10 Feb. 11, 2025

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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: 05-08 years
Job Type: Full-Time

Job Summary:

ProRelix Research is looking for a skilled and dynamic Team Lead (Clinical Trial Operations) with 5-8 years of experience in managing clinical trials. This role requires a seasoned professional who can lead and mentor a team of clinical trial operations staff, ensuring that all clinical trials are executed efficiently and comply with regulatory standards. The Team Lead will be responsible for overseeing day-to-day operations of clinical trials, optimizing processes, and ensuring high-quality data collection across multiple projects.

Key Responsibilities:

Clinical Trial Operations Management:
- Oversee and manage the execution of clinical trials, ensuring they are completed on time, within budget, and in compliance with regulatory requirements.
- Lead the team in the planning, coordination, and implementation of clinical trial activities from study initiation to closeout.
- Ensure the proper preparation and maintenance of all trial documentation, including regulatory submissions, ethics approvals, and informed consent forms.
- Ensure the compliance of trial operations with Good Clinical Practice (GCP), local regulations, and ProRelix Research policies.
Team Leadership and Mentorship:
- Lead, mentor, and provide direction to a team of clinical trial coordinators, clinical research associates (CRAs), and other clinical trial staff.
- Foster a collaborative environment, ensuring effective communication and problem-solving within the team.
- Provide coaching and training to team members, ensuring continuous skill development and adherence to best practices.
Project Planning and Coordination:
- Develop and manage the clinical trial project plan, including timelines, resources, and risk mitigation strategies.
- Coordinate with cross-functional teams (e.g., regulatory, medical, data management) to ensure smooth execution of trials.
- Track trial progress, identify issues, and implement corrective actions to maintain study timelines and ensure adherence to project objectives.
Site Management and Monitoring:
- Ensure appropriate site selection, training, and initiation processes to ensure that clinical trials are initiated according to regulatory guidelines and study protocols.
- Provide ongoing site management and monitoring of clinical trial progress to ensure quality, compliance, and patient safety.
- Act as a point of contact for sites and external stakeholders to address any issues related to trial execution.
Risk Management and Compliance:
- Identify, evaluate, and mitigate risks related to clinical trials, including patient recruitment challenges, data collection issues, and site-related problems.
- Ensure that adverse events (AEs) and serious adverse events (SAEs) are properly reported and addressed.
- Maintain a high level of compliance with regulatory requirements (FDA, EMA, ICH-GCP, etc.) and ProRelix Research SOPs.
Budget and Resource Management:
- Monitor and manage the budget for clinical trials, ensuring resources are allocated effectively and within budget.
- Ensure that necessary resources, such as clinical trial supplies and personnel, are available for the successful execution of trials.
- Work closely with finance to track spending and ensure cost-efficiency throughout the trial lifecycle.
Reporting and Documentation:
- Prepare and present regular reports to senior management on the status of ongoing trials, including trial progress, milestones, issues, and risks.
- Oversee the preparation of key trial documents (e.g., study protocols, informed consent forms, investigator brochures) and ensure timely submission and approval.
- Maintain detailed trial documentation, ensuring all records are accurate, complete, and readily available for audits and inspections.

Key Skills & Qualifications:

Educational Qualification:
- Bachelor’s degree in Life Sciences, Pharmacy, or related field (B.Sc, M.Sc, B.Pharm, M.Pharm).
- A Master’s degree in a relevant field is a plus.
Experience:
- 5-8 years of experience in clinical trial operations or clinical research, with at least 2-3 years in a leadership or supervisory role.
- Experience in managing multi-site or multi-country clinical trials.
- Experience in biologics, biosimilars, or other complex therapeutic areas is desirable.
Technical Skills:
- Strong knowledge of clinical trial management, clinical operations, and regulatory requirements (GCP, ICH, FDA, EMA).
- Familiarity with clinical trial management software (CTMS) and electronic data capture (EDC) systems.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
Leadership Skills:
- Proven ability to lead, motivate, and manage a team of clinical research professionals.
- Strong decision-making and problem-solving skills, with the ability to resolve issues and ensure trial success.
- Excellent project management and organizational skills, with the ability to manage multiple tasks and priorities.
Soft Skills:
- Excellent verbal and written communication skills in English.
- Strong interpersonal skills and the ability to build and maintain relationships with internal teams, external clients, and clinical trial sites.
- Ability to handle pressure and maintain professionalism in a fast-paced environment.

Why ProRelix Research?

Career Growth:
ProRelix Research offers the opportunity for significant career advancement within the clinical research industry, with a focus on continuous learning and development.
Innovative Environment:
You will work alongside a dynamic team of professionals dedicated to delivering quality research and making impactful contributions to the biopharmaceutical industry.
Competitive Compensation:
We offer competitive compensation packages, with benefits designed to support your professional and personal needs.

Interested candidates are encouraged to send their CVs to career@prorelixresearch.com to explore career opportunities with ProRelix Research.

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Team Lead (Clinical Trial Operations)

Job Description

Job Summary:

Key Responsibilities:

Key Skills & Qualifications:

Why ProRelix Research?

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