Biodexa Pharmaceuticals is a clinical stage biopharmaceutical company based in Cardiff, developing a pipeline of products aimed at primary and metastatic cancers of the brain. The company’s lead candidate, MTX110, is being studied in multiple serious and aggressive brain cancer indications including recurrent glioblastoma and diffuse midline glioma.
The Clinical Project Manager (CPM) will oversee the planning, implementation and management of Biodexa Pharmaceuticals’ clinical operations research projects. The CPM will work with internal R&D functions and external partners, including key opinion leaders (KOLs), CROs and specialist consultants, to coordinate development of key clinical trial documents and manage Trial Master Files (TMF) in accordance with Company SOPs and Policies.
• Coordinate the development of clinical trial protocols in collaboration with CROs, in-house scientists, investigators, KOLs and other subject matter experts
• Prepare or oversee, as appropriate, study documentation for clinical study files according to company SOPs and regulatory guidelines
• Lead cross-functional teams to ensure project objectives are met within timelines and budget
• Ensure compliance with regulatory requirements and SOPs
• Develop and maintain strong relationships with key stakeholders, including clinical trial sites, vendors, and study participants
• Proactively identify and manage risks and issues
• Develop and implement communication plans to ensure clear and timely communication of project status, updates, and issues to key stakeholders
• Ensure that data is collected, managed, and analysed in accordance with protocol requirements and timelines
• Contribute to development, and periodic review, of clinical SOPs within the overall clinical quality management system
• Ensure all clinical trial activities undertaken comply with SOPs, ICH/GCP, EU Directive, statutory instruments and local regulatory requirements
• Assist in the evaluation, selection and management of clinical CROs.
• Be responsible for routine communication with CROs and study sites, as necessary, and assist with site initiation activities.
• Accountable for set up, QC and management of study TMFs
• Responsible for maintenance of clinical operations documentation to inspection readiness standard
• Liaise with data management vendors to ensure data are reported accurately and in a timely manner
Qualifications and requirements:
• Batchelor’s or Master’s degree in scientific or healthcare field
• 5+ years of experience in clinical trial industry, with a minimum of 2 years of project management experience, preferably within the pharmaceutical or biotech industry. Strong vendor management experience.
• Strong understanding of clinical trial operations and regulations
• Excellent communication, leadership and interpersonal skills
• Proven ability to manage cross-functional teams and work collaboratively with internal and external stakeholder
• Strong analytical and problem solving skills
• Experience with project management tools and software. Experience with Asana is advantageous
• Experience with drug/device combinations is advantageous, but not essential
• Ability to work independently, prioritize tasks, and meet deadlines
• Flexibility to adapt to changing project requirements and timelines
Remote applicates from the UK are welcome but travel to Cardiff will be required.
Please send CV and a covering letter to firstname.lastname@example.org
|Minimum education level||Bachelor’s or Master’s degree in scientific or healthcare field|
|Industrial experience||5+ years of experience in clinical trial industry, with a minimum of 2 years of project management experience, preferably within the pharmaceutical or biotech industry. Strong vendor management experience in a relevant industrial setting is essential.|
|Supervision received by the role||The successful candidate will report directly to VP, Head of Clinical Operations.|
|Supervisory responsibility||Supervision of other staff will be subject to experience.|
Clinical Project Manager
VP, Head of Clinical Operations
How to Apply
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