A fantastic opportunity has become available for a Clinical Project Manager in London. The opportunity will be working for a biopharmaceutical company focused on the development of T cell therapies targeting clonal neoantigens for the treatment of cancer. The Clinical Project Manager will become one of the leaders within their close-knit team, responsible for coordinating and managing allocated studies. This would be ideal for an experienced Clinical Project Manager who has CRA experience.
On offer for the Clinical Project Manager is a competitive salary and benefits package which can be disclosed upon application. The role is office based but there may be negotiation on some remote working depending on the location of the candidate.
Key Responsibilities of the Clinical Project Manager
- Play a pivotal role in the Clinical Operations team leading clinical studies within a programme.
- Act as an expert in your therapy area, working independently with guidance in only the most complex situations.
- Serve as a close partner to the study physicians, coordinating the activity of research teams and holding full accountability for projects, often with global impact.
- This position will have key relationships with internal stakeholders within the clinical project team, as well as externally with KOLs, investigators and external service providers.
- Lead the development and design of studies to determine the scientific viability of a particular cell product and interpret the results of these studies, either as the head of a team, or by providing expert input.
- Support the protocol writing and strategy in conjunction with other key members of the project team.
- Review and interpret medical data and clinical trial data, draw conclusions, and potentially identify new research and development opportunities.
- Create/Review patient consent forms and provide relevant opinion.
- Have responsibility for delivery of components of clinical trials.
- The overall efficient day-to-day clinical trial management of studies.
- Manage timeline adherence, trial budgets and project quality deliverables.
- Interact with and manage vendors.
- Manage contract requirements.
- Serve as the primary contact for all protocol clarifications and logistical project related issues.
- Establishment of procedures to ensure adherence to trial protocols and performing amendments where necessary.
- Work with the Investigators to ensure that the studies are meeting targets, producing meaningful output and then to predict and plan any changes that warrant requests to changes in protocol, funding, or time.
- Assist in study start-up activities including site selection and review of essential regulatory documentation.
- Perform occasional interim monitoring visits, including site qualification, initiation, and close-out. Including the source data verification of CRFs and Data clarification forms as stipulated.
- Manage the collection of data from sites within established timelines.
- Co-ordinate the preparation and publication of data, reports, and information, ensuring that these meet legislative, contractual and ethical requirements.
- Maintain Project documents in accordance with ICH-GCP, HTA and company SOPs.
- Collaborate with site personnel, EC/IRB, Competent Authorities/MOH contractors and company personnel.
- Prepare, coordinate and present at Investigator meetings, other study trainings and project meetings as required.
- Be prepared to travel internationally for the role.
- Any other ad-hoc tasks as required.
- Be responsible for adhering to all health and safety guidance, provided by the Company.
Experience required:
- Bachelor’s degree (BSc, BA or RN equivalent) in a biological or science-related field is essential.
- 2-5 years ‘experience as a Clinical Project Manager in Pharma/Biotech
- 6-8 years’ experience in oncology clinical studies, ideally early phase
- Strong experience in immune-oncology early phase and cell therapy
- Excellent communication and collaboration skills
- Strong experience in global setting and matrix environment
- Strong experience in partnering with diverse teams and delivering results through taking ownership of key programmed components.
- Previous experience of site monitoring in oncology studies
- Strong clinical, technical or disease area expertise
- Knowledge of medical terminology and clinical patient management
- Experience with ATIMPs an advantage
- Ability to establish and maintain effective working relationships with co-workers, managers, investigator site personnel and service providers.
- Thorough knowledge of ICH-GCP guidelines, EU directives and FDA regulations
- Ability to manage multiple projects.
- Excellent communication, interpersonal and organisational skills.
- Effective problem-solving skills
- Attention to detail and timelines.
- Computer literacy, proficiency in Microsoft Office
- Computer literacy, proficiency in Microsoft Office. Preferably experienced with the use of eCRFs and eTMF
- Ability to work independently and to effectively prioritise tasks.