Clinical Project Manager
- Bioplus Life Sciences
- 10 - 12 years
- Bengaluru
- 10 days ago
- Email to a friend
- Report this job
Job Description
Interested candidates are requested to apply to ta***t@bi****s.in
Role & responsibilities :
Key Responsibilities
- Serve as the primary operational lead for assigned clinical studies from initiation through study closeout.
- Develop and manage detailed project plans, timelines, budgets, and risk mitigation strategies.
- Oversee selection, qualification, and performance management of CROs, vendors, and investigators.
- Lead vendor and site start-up activities including CTA negotiation, ethics/regulatory submissions, and essential document readiness.
- Ensure effective cross-functional communication and alignment among internal stakeholders (Clinical Operations, Regulatory, QA, Data Management, Biostatistics, and Medical Affairs).
- Track study metrics (enrollment, data quality, monitoring compliance, budget utilization) and implement corrective actions when needed.
- Prepare and present study progress reports to senior management and governance committees.
- Ensure adherence to ICH-GCP, local regulatory requirements, company SOPs, and study protocols.
- Manage study budgets, including forecasting, variance analysis, and cost control.
- Lead or contribute to process improvement initiatives, SOP development, and operational excellence programs.
Preferred candidate profile
- Bachelors or Masters degree in Life Sciences, Pharmacy, Medicine, or related discipline.
- 1012 years of overall experience in Clinical Operations, of which at least 56 years in Clinical Project Management and cross-functional trial leadership.
- Experience working in both CRO and Sponsor organizations is highly desirable.
- Proven track record of global/multi-center clinical trial management across all study phases (IIV).
- Strong understanding of ICH-GCP, regional and global regulatory frameworks (FDA, EMA, CDSCO and others).
- Demonstrated experience in vendor oversight, budget and contract negotiation, resource and risk management.
- Excellent organizational, communication, and leadership skills.
- Ability to work effectively in a fast-paced, dynamic, and cross-cultural environment.
- Proficiency in MS Office, project management tools, and EDC/CTMS/eTMF systems.
- PMP or equivalent project management certification is an added advantage.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Project & Program ManagementRole Category: Other Program / Project ManagementRole: Project ManagerEmployement Type: Full timeContact Details:
Company: Bioplus Life SciencesLocation(s): Bengaluru+ View Contact
Keyskills: Clinical Research Clinical Operations Clinical Trials
Fraud Alert to job seekers!
₹ Not Disclosed
Similar positions
Bioplus Life Sciences
Bioplus has over 500 employees including scientists, pharmacists and staff who are dedicated to research, manufacturing and marketing of pharmaceuticals worldwide. Established since 1946, we have operations in most regulated markets over 60 countries. Our research efforts are focus...
Job Listings
We are in open beta version of website, please let us know if any issues, at: info(at)indigojobs.in