Clinical Operations Lead

12+ years

Not Disclosed

Hyderabad

10 Jan. 3, 2025

Job Description

Job Type: Full Time Education: B. Pharm./M. Sc. (Life science)/ M. Pharm./M.B.B.S./Ph.D 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: Clinical Operations Lead – Biosimilars
Location: India
Department: Clinical Operations
Date: Immediate

Job Overview

We are looking for an experienced Clinical Operations Lead to manage and execute clinical trials in the biosimilar domain. This leadership role will involve vendor identification, evaluation, and selection, alongside strategic input into clinical trial execution plans. The role also includes ensuring compliance with clinical trial strategies and managing vendor relationships for successful trial completion. The ideal candidate will possess significant experience in clinical research, biosimilar studies, and people management.

Key Responsibilities

CRO/Vendor Identification & Management:
- Lead the process for identifying, evaluating, and selecting CROs/vendors, including the preparation and rollout of RFI and RFPs.
- Assess responses and shortlist potential CROs for further comparison and discussions with HOD and senior leadership.
- Participate in vendor selection visits as a Clinical Operations Subject Matter Expert (SME) and facilitate the final vendor selection process.
Clinical Trial Execution:
- Contribute to the development of clinical trial execution strategies and plans, ensuring alignment with clinical development strategies.
- Define recruitment initiatives in coordination with CROs/vendors and ensure timely recruitment and enrollment.
- Review and finalize clinical trial documents and plans such as Study Monitoring Plans, Project Management/Communication Plans, and RACI matrices.
- Provide input into key study documents (e.g., protocol, informed consent forms (ICFs), case report forms (CRFs)).
- Monitor compliance with sponsor oversight plans by reviewing monitoring reports, CRF data, and monthly listings/reports, and conducting onsite visits as necessary.
Functional Capability Building:
- Develop and review SOPs, Work Instructions, and study manuals for continuous improvement in clinical operations.
- Consolidate lessons learned and share best practices with cross-functional teams to ensure continuous learning and development.
End-to-End Vendor Management:
- Build and maintain strong, collaborative relationships with CROs/vendors to ensure the effective execution of clinical trials.
- Conduct face-to-face meetings with vendors as required to address issues and ensure smooth project execution.
Governance and Reporting:
- Participate in various governance meetings, including internal and external project team meetings, data management calls, and other cross-functional reviews.
- Ensure timely and effective communication in all governance meetings (e.g., PTM, CPR, N-CC apex meetings).
People Management:
- Conduct goal-setting, performance appraisals, mentoring, and coaching for team members.
- Collaborate with the HOD in manpower planning, recruitment, and identifying team training needs.
- Provide training on new processes to ensure team readiness and growth.

Qualifications

Educational Qualifications: Master’s/Bachelor’s Degree in Life Sciences or Allied Medical Fields (e.g., B. Pharm, M. Sc. Life Science, M. Pharm, M.B.B.S., Ph.D.)
Experience: Minimum of 12 years of clinical research/operations experience, with at least 2 years in biosimilar studies and 2 years in people management.
Business Understanding:
- In-depth knowledge of biosimilar development and the regulatory guidance for clinical trials in India and other global regulatory agencies.
- Familiarity with biosimilar competitive intelligence, clinical trial execution technologies (e.g., DM, IWRS, safety platforms), and various therapeutic areas such as Oncology, Rheumatology, and Dermatology.
- Knowledge of clinical development basics, global regulatory frameworks, IP supply management, and vendor relationship governance.

Behavioral Skills:

Ability to work in ambiguous situations with strong strategic thinking and execution capabilities.
Skilled at aligning cross-functional teams to achieve successful outcomes.
Proactive, self-initiated, and resilient in dynamic environments.
Excellent communication (verbal and written), negotiation, and planning skills.
Strong interpersonal and influencing skills for effective collaboration.

Why Join Us?

This is a unique opportunity to lead clinical operations in a growing organization within the exciting field of biosimilars. We offer a collaborative environment where you can make a tangible impact on the success of clinical trials, with opportunities for professional development and growth. If you're passionate about biosimilars, clinical trials, and people management, we'd love to have you on board.

Let me know if you'd like to make any changes!

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Clinical Operations Lead

Job Description

Job Overview

Key Responsibilities

Qualifications

Behavioral Skills:

Why Join Us?

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