Drive Regional Clinical Trial Excellence for Groundbreaking Therapies
We are seeking an experienced Clinical Trial Operations Manager to take ownership of end-to-end clinical trial execution at the regional and country level. In this pivotal role, you will be the key leader ensuring the operational excellence, compliance, and timely delivery of clinical trials within your assigned region. Your expertise will bridge global strategy and local execution, directly impacting the development of new therapies for patients.
Your Mission: Regional Trial Strategy & Execution
You will be the single point of accountability for all clinical trial activities within your region or operational unit (R/OPU). Your focus will be on translating global trial protocols into efficient, compliant, and successful local operations.
Key Responsibilities:
Strategic Trial Planning & Start-Up:
- Lead country-level feasibility, site selection, and patient engagement strategy, leveraging local insights to optimize trial design and recruitment.
- Develop and manage the regional trial budget, ensuring financial accuracy and oversight throughout the trial lifecycle.
- Oversee all trial preparation activities, including vendor management, regulatory/ethics submissions, and ensuring all teams are trained and aligned for a successful start.
Operational Oversight & Conduct:
- Maintain end-to-end oversight of trial conduct, ensuring strict adherence to GCP-ICH, local regulations, and company SOPs.
- Proactively monitor patient recruitment and trial progress, implementing risk mitigation strategies to keep the trial on track.
- Serve as the primary point of contact for regional investigators, sites, and patient organizations, building strong relationships to facilitate smooth trial operations.
Trial Close-Out & Knowledge Sharing:
- Ensure timely and compliant data delivery, trial document archiving (TMF), and submission of clinical trial reports to local authorities.
- Share trial results with investigative sites and contribute regional insights to improve future trial designs and processes.
Leadership & Influence:
- Champion a culture of high performance, continuous improvement, and empowerment within the regional and global clinical operations teams.
- Apply a strategic mindset to navigate complexity, embrace innovative technologies, and drive decisions that accelerate clinical development.
About You: The Ideal Candidate
You are a proactive, strategic leader with a proven track record of delivering clinical trials on time, within budget, and to the highest quality standards.
Required Qualifications & Experience:
- University degree (Masters or equivalent) in a Biomedical or Life Sciences field.
- Several years of strong clinical trial project management experience, with in-depth knowledge of GCP-ICH and local/regional regulatory requirements.
- Demonstrated leadership in a matrix environment, with excellent communication, influencing, and stakeholder management skills.
- Proven ability to manage budgets, oversee CROs/vendors, and drive operational excellence.
Desired Skills & Mindset:
- Experience in relevant Therapeutic Areas is highly desirable.
- Strategic, forward-thinking leader who empowers teams and fosters a learning culture.
- Ability to navigate ambiguity, take smart risks, and translate complex challenges into actionable plans.
Why This Role is a Career-Defining Opportunity:
This position places you at the critical intersection of global strategy and local execution. You will have the autonomy to shape trial success in your region while contributing to the broader mission of bringing new therapies to patients faster. It's an opportunity to build and maintain key external expert relationships and drive real change in clinical development.
We Offer:
- A remote-friendly work environment (#LI-REMOTE)
- The chance to work on a diverse pipeline of clinical trials
- A culture that values empowerment, innovation, and one-team collaboration
- Professional growth in a role that balances strategic impact with operational rigor
