Clinical Project Manager, EMEA

Telix Pharmaceuticals Limited; Herstal; Sur place; EUR 65 000 - 95 000; Plein temps

Résumé du poste

Telix Pharmaceuticals Limited is seeking a Clinical Project Manager to lead day-to-day responsibilities of multiple early‑phase regional trials from protocol conception through the study report, ensuring GCP compliance, quality data, and on‑budget delivery.

The CPM will partner with CROs and vendors, coordinate cross-functional teams, and drive risk management, TMF integrity, and timely milestone achievement in a fast-paced environment.

Qualifications

• Bachelor's degree in life sciences.
• Minimum 2 years in clinical trial project management.
• Experience in early phase trials (Phase 1-2) preferred.
• Familiar with ICH GCP and regulatory processes.
• Strong cross-functional collaboration and problem-solving.

Responsabilités

• Support planning, setup, maintenance and closeout of multiple trials.
• Manage trial budgets, timelines, resources and vendor relationships.
• Oversee CROs, vendors and investigational sites with cross‑functional teams.
• Monitor external partner performance against timelines and budget.
• Draft and update Protocols, ICFs, Investigator’s Brochure and manuals.
• Ensure study plans follow SOPs and regulatory requirements.
• Identify risks and resolve issues to keep timelines on track.
• Coordinate TMF, data collection, safety reporting and analytics.
• Lead small to medium regional, multi-center trials.
• Assist with TMF audits and study close-out.
• Perform other duties as assigned by management.

Connaissances

Trial management

Vendor management

Regulatory knowledge

ICH GCP

CTMS/eTMF

Stakeholder leadership

Formation

Bachelor's degree in life sciences

Outils

CTMS

eTMF

Description du poste

The Clinical Project Manager (CPM) is responsible to support and oversee the day-to-day responsibilities of multiple early phase regional clinical trials from protocol conception, start-up through the clinical study report, including all aspects of project document development, budget, safety, and quality in an environment where problem solving, critical thinking, teamwork and flexibility are vital to success. The CPM will work closely with CROs and/or third-party vendors and closely collaborate with cross-functional internal and external stakeholders to ensure adherence to GCP, SOPs, and FDA/ICH guidelines and ultimate delivery of high-quality data within the defined timelines and approved budget. The CPM ensures completion of study deliverables and proactively identifies and resolves clinical project issues.

Key Accountabilities:

• Support the planning and setup, maintenance and closeout phases of multiple concurrent clinical research studies
• Proactively managing all aspects of the trial process including vendor selection, site feasibility and selection, trial clinical timelines, clinical budgets, resources, and vendor relationships
• Provide day-to-day study management including, but not limited to oversight of CRO, study vendors and investigational sites in coordination with various cross-functional team members and study team.
• Monitoring all work performed by the external partners to ensure quality of the service with respect to mutually agreed timelines and budget.
• Support the drafting, review and updating of documents related to clinical development such as Clinical Trial Protocols, Informed Consent Forms, Investigator’s Brochure, Laboratory Manual, IMP Handling Manual, etc.
• Ensuring effective project plans are in place and operational for each trial within trial appropriate SOPs
• Identify and mitigate risks and apply strong problem-solving skills to ensure timely resolution of all study related issues
• Manage, facilitate and/or monitor the completion of interdisciplinary project tasks including site monitoring/audits, CRF and database development / revision, data collection, patient safety / AE management, document management, statistical analysis / final report writing, and study close out.
• Management of small or medium-sized projects or regional leadership of complex multi-center clinical research project
• Oversee the study specific Trial Master File (TMF) and assist with periodic audit of the TMF
• Perform any other tasks/duties as assigned by management

Position Requirements

Education and Experience:

• Bachelor’s degree in life sciences
• At least 2 years of relevant experience in Clinical Trial Project Management
• Strong understanding of all aspects of clinical trials; experience with early phase clinical trials (Phase 1 - 2), oncology and/or radiopharmaceutical experience preferred.
• Ability to deal with multiple priorities with aggressive timelines.
• Thorough knowledge of ICH GCP, drug development, clinical research industry practices and regulatory processes.
• Strong analytical, organizational, planning, decision making, negotiation, and conflict management skills.
• Ability to build and maintain successful professional relationships with internal cross-functional teams, vendors and investigational sites.
• Fluent in Microsoft Office products (Word, Excel, SharePoint, Teams, etc.) and proficiency using electronic platforms (CTMS, eTMF).
• Regional start-up experience (site feasibility, ethics & regulatory submissions)
• Demonstrated ability to pivot study strategy quickly and lead teams in the right direction working in a fast-paced environment.
• Experience in conflict resolution, clinical project management practice, risk management, and an understanding of project financials.

Key Capabilities:

• Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do
• Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results
• Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges
• Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language
• Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals
• Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges
• Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected
• Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges
• Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders
• Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills