The Clinical Trial Manager directs and/or supports the planning and management of clinical trials in an outsourced environment. The role is responsible for effective CRO and vendor management and oversight, supports and conducts co-monitoring activities, and works closely with internal and external stakeholders to ensure that clinical trials are delivered in line with the required quality standards, timelines, budget, and corporate objectives, while complying with ICH-GCP, applicable regulatory requirements, and company processes.
The position requires a pragmatic, hands-on individual who is comfortable taking ownership, managing external partners, identifying and resolving operational issues, and working effectively within a dynamic biotech environment.
Key Responsibilities
- Manage and/or support the operational planning and execution of clinical trials from study start-up through conduct and close-out.
- Act as a key operational contact for CROs, clinical sites, and other external vendors.
- Manage and oversee CRO and vendor activities, deliverables, timelines, quality, and budgets, including proactive identification and escalation of performance issues.
- Participate in CRO/vendor selection, bid-defense activities, contracting and periodic performance assessments.
- Support country and site feasibility, selection, activation, management, and close-out activities.
- Maintain in-depth knowledge of the study protocol, operational requirements, and study plans.
- Develop, review, and maintain study plans, manuals, trackers, and other trial-specific documentation.
- Conduct sponsor co-monitoring visits and review monitoring visit reports to ensure appropriate site oversight and monitoring quality.
- Oversee study budgets, forecasts, invoices, purchase orders, and change orders as applicable.
- Support the set-up, testing, and maintenance of clinical trial systems, as applicable, such as EDC, IRT, eTMF and other study platforms.
- Provide clear and timely study status updates to internal stakeholders and senior management.
- Maintain up-to-date knowledge of applicable clinical trial regulations and guidelines and ensure studies are conducted in accordance with ICH-GCP, applicable regulatory requirements, the protocol, and company procedures.
Qualification Requirements
- Master’s degree or higher in life sciences, healthcare or related discipline
- > 2 years of experience with management of clinical trials in the biotech, pharmaceutical and/or CRO environment, excluding monitoring experience
- Experience with management and oversight of CROs and vendors
- Clinical site monitoring experience (CRA), preferably in oncology
- Robust understanding of operations on global multi-center trials
- Solid knowledge of drug development regulations (ICH-GCP, EMA, FDA, local regulations)
- Ability to travel on planned and short-term notice
Competencies and Personal Skills
- Good communication skills
- Ability to write in a clear, focused and concise manner
- Detail-oriented with a strong focus on clinical trial quality and compliance
- Good organizational and time management skills
- Ability to work independently in a team environment
- Strong team player with a desire to contribute in a highly dynamic, professional, and growing biotech team
Why CDR-Life?
Enter a meaningful job with purpose – helping people with cancer and other incurable diseases. Become part of a team on a mission with a collaborative, open, and solution-oriented spirit where you can have an impact. Enjoy exciting opportunities for development and professional growth within our growing organization with flexibility that fits with your needs and lifestyle, as well as competitive salary and benefits.
We are looking forward to hearing from you.
CDR-Life is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants without regard to religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status or any other characteristic protected by law.
Please note CDR-Life operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with CDR-Life, all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of CDR- are considered the property of CDR-Life and are not subject to payment of any form of introduction, placement, or referral fees.