Clinical Research Associate-BA/BE studies

Job description: Clinical Research Associate/ Project Manager– Bioequivalence (BE) Studies

Job Summary

The Clinical Project Manager (CPM) is responsible for the end-to-end management of sponsor-led bioequivalence (BE) studies conducted at Contract Research Organizations (CROs). The CPM ensures studies are delivered on time, within budget, and in compliance with regulatory requirements including U.S. Food and Drug Administration, European Medicines Agency, and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines.

The role serves as the primary liaison between the sponsor and CRO, overseeing study planning, execution, data review, reporting, and submission readiness.

Key Responsibilities

1. Study Planning & Start-up

- Lead cross-functional study planning activities (Clinical, Regulatory, QA, Bioanalytical, PK, Data Management). - Develop and review study protocols for bioequivalence trials (fasted/fed, replicate, parallel designs). - Select and manage CROs and bioanalytical laboratories. - Review and approve study-related documents: - Protocol and amendments - Informed Consent Forms (ICF) - Investigator’s Brochure (if applicable) - Case Report Forms (CRFs) - Ensure regulatory strategy aligns with ANDA/MAA submission requirements.

2. CRO & Vendor Management

- Serve as primary sponsor contact for CRO. - Conduct kickoff meetings and routine oversight meetings. - Review and approve: - Study timelines - Monitoring plans - Bioanalytical method validation reports - Clinical study reports (CSR) - Track KPIs and ensure adherence to contractual obligations. - Manage issue escalation and risk mitigation strategies.

3. Study Conduct Oversight

- Monitors BA/BE studies to ensure compliance with protocols, regulations, and data quality standards. - Ensure compliance with: - ICH-GCP - Applicable regulatory authority requirements - Oversee: - Subject recruitment and dosing progress - Safety reporting - Protocol deviations - Data quality and query resolution - Review interim data and PK data outputs.

4. Bioanalytical Oversight

- Review bioanalytical method validation and sample analysis reports.

5. Budget & Timeline Management

- Develop and manage study budgets. - Review CRO invoices and change orders. - Monitor study milestones and ensure on-time database lock and CSR finalization.

6. Regulatory & Submission Support

- Ensure TMF completeness and audit readiness. - Support preparation of: - Module 5 documents for ANDA/NDA submissions - Address regulatory queries related to clinical or BE data.

7. Risk Management & Quality Oversight

- Identify operational risks early and implement mitigation plans. - Participate in vendor audits and quality reviews. - Ensure CAPA implementation when required.

Qualifications

Education

- Bachelor’s or Master’s degree in: - Pharmacy - Life Sciences - Clinical Research - Pharmacology

Experience

- 5+ years of experience managing bioequivalence studies. - Sponsor-side experience strongly preferred.

Technical Knowledge

- Strong understanding of: - Bioequivalence study designs - PK principles - GCP and regulatory guidelines - Clinical study report structure (ICH E3) - Familiarity with electronic TMF systems and clinical databases.

Core Competencies

- Strong project management skills - Vendor oversight and negotiation - Risk-based monitoring oversight - Budget management - Cross-functional leadership - Excellent communication and stakeholder management