Clinical Trial Manager

Key Responsibilities:

• Clinical Trial Planning:

  Develop and execute comprehensive clinical trial plans, protocols, and study timelines in compliance with all relevant regulatory guidelines (e.g., ICH-GCP, FDA regulations).

• Site Management:

  Identify, qualify, and manage clinical trial sites and investigators. Ensure proper site initiation, monitoring, and closure.

• Study Oversight:

  Supervise all aspects of the Phase II clinical trials, including patient recruitment, data collection, and case report form (CRF) completion.

• Budget & Vendor Management:

  Manage trial budgets and timelines. Oversee and coordinate activities of contract research organizations (CROs) and other third-party vendors.

• Quality Assurance:

  Implement and maintain quality control processes to ensure data integrity and adherence to the study protocol.

• Regulatory Compliance:

  Prepare and submit necessary documentation to regulatory authorities and ethics committees. Address any queries or requests from regulatory bodies.

• Team Leadership:

  Lead and mentor a team of clinical research associates (CRAs) and other support staff to ensure efficient trial execution.

• Problem-Solving:

  Proactively identify potential issues and risks and develop effective mitigation strategies.

Preferred Candidate Profile

We are looking for a skilled professional with a proven track record of success in clinical trial management. The ideal candidate will possess:

• Experience:

  A minimum of 10-12 years of experience in managing clinical trials, with significant experience in

  Phase II and Phase III

  trials.

• Education:

  A Bachelor's or Master's degree in a life science, health science, or a related field. A doctoral degree (Ph.D., Pharm.D., M.D.) is a plus.

• Expertise:

  In-depth knowledge of the drug development process and strong familiarity with

  oncology

  is highly desirable.

• Regulatory Knowledge:

  Comprehensive understanding of Good Clinical Practice (GCP) guidelines, ICH regulations, and local regulatory requirements.

• Skills:

  Exceptional project management, communication, and interpersonal skills. Must be a strategic thinker with a keen eye for detail.

• Leadership:

  Demonstrated leadership ability with experience managing teams and external vendors.

  Role & responsibilities

Key Result Areas (KRAs)

The performance of the Manager of Clinical Trials will be measured against the following Key Result Areas:

• Trial Initiation & Timeline Adherence:

  Achieve timely initiation of all three Phase II clinical trials (Oral, Lung, and Pancreatic Cancer) within the planned timelines.

• Patient Recruitment:

  Meet and exceed patient enrolment targets for each indication to ensure statistical power and timely data analysis.

• Budget Management:

  Ensure clinical trial expenditures remain within the approved budget by effectively managing resources and vendor contracts.

• Data Integrity & Quality:

  Maintain a high level of data quality and integrity, as evidenced by a low rate of protocol deviations and clean database lock.

• Regulatory Submissions:

  Achieve successful and on-time submission of all required regulatory documents and obtain timely approvals from regulatory bodies.

• Team Performance:

  Foster a high-performing team environment, resulting in the successful achievement of project milestones and objectives.

About Vopec

Vopec Pharmaceuticals Private Limited: Pioneering Cancer Therapeutics

Join Vopec Pharmaceuticals, a Chennai-based clinical-stage biotech driving innovation in oncology. Our lead program, AB001, is a next-generation small-molecule immunotherapy targeting PD-L1 and multiple cancer pathways, with US FDA Orphan Drug Designations for pancreatic cancer, glioblastoma multiforme, and acute myeloid leukemia. Following strong Phase 1 safety and efficacy results, we are now advancing into Phase 2 trials for oral, lung, and pancreatic cancersoffering a rare opportunity to work on a globally significant, first-in-class cancer therapeutic.

As we expand our clinical development program, we are seeking a talented and driven Manager of Clinical Trials to lead the execution of our Phase II studies for AB001 across three critical indications: Oral Cancer, Lung Cancer, and Pancreatic Cancer. This is an incredible opportunity to join a passionate team at the ground floor of an innovative oncology program and make a tangible difference in the lives of patients worldwide.

Visit : https://www.vopecpharma.com/drug-development

Contact :

Mrs.Chitra

Group Head HR

Vopec Pharmaceuticals Pvt Ltd,

B-13, Mogappair Industrial Estate,
Mogappair West,Chennai - 600 037. INDIA

grouphr@vopecpharma.com

Mob : 95000 77040