Clinical Research Manager
A leading biopharmaceutical company, which develops and commercialises medicines in Oncological, Neuroscience, and Rare Disease fields, is currently recruiting for a Clinical Research Manager. This company boasts an extremely impressive portfolio of therapies for prostate cancer, neuroendocrine tumours, and renal cell carcinoma, along with medicines for cervical dystonia, hemifacial spasm, and paediatric lower limb spasticity. Based in the company's UK office, this role is an exciting opportunity to bring experience and dedication to this internationally successful company.
- Forecasting country resource needs and serving local business needs.
- Acting as a country point of contact for assigned protocols and proactively driving/tracking execution and performance of deliverables/timelines/results to meet country commitments.
- Creating and distributing relevant reports to key stakeholders.
- Ensuring the quality and compliance with protocols in the country.
- Performing quality control visits, reviewing Monitoring Visit Reports, and escalating performance issues and training needs to functional vendor and internal management as needed.
- Collaborating and managing relationships with investigators for insourced studies, with functional outsourcing vendors, and other external partners.
- Overseeing country and site validations, site selection, and recruitment in assigned protocols.
- Liaising with Global Medical Affairs where appropriate.
- Acting as the main point person for any escalations.
- Setting up the study team and lead study initiation meeting
- Leading study submissions for internal review to the MARB in conjunction with the study medical lead (synopsis and protocol).
- Selecting the CRO(s) in collaboration with study medical lead, purchasing department, and UK Legal team.
- Managing the production of all documents necessary to implement and conduct the study.
- Identifying and selecting the study sites in collaboration with the Study Medical lead and CRO (where appropriate).
- Coordinating the set-up of the Trial Master File in collaboration with the CRA/Project Manager assigned to the study.
- Ensuring that the study team and the study sites have been appropriately trained (investigator's meeting) in collaboration with study medical leads and therapy area MSL.
- Ensure the posting of the study on the required registries.
- Overseeing the progress of the study to ensure it is delivered on time and within budget.
- Coordinating the study team (internal and external) with regular meetings/teleconference/Virtual meetings.
- Recommending and reviewing amendments to study protocol if needed.
- Providing regular reports on the study progression including site performance, schedule, and resources.
- Overseeing regular newsletter preparation that informs and motivates investigators and study team.
- Ensuring that CTMS is updated in a timely manner.
- Coordinating with the Medical Lead [JB1] and corporate functions to oversee the preparation, the review, and the posting of the CSR.
- Ensuring the finalisation and archiving of the TMF.
- Ensuring that the study results are posted on the required registries.
- Working with medical lead in conjunction with internal and external stakeholders in delivering a publication in accordance with good publication planning.
- Working with Internal global publications team to ensure the company review and local and global SOPs and regulations are met.
Skills and Requirements:
- Bachelor's life science degree or Master's degree or equivalent / PhD or MD.
- 5+ years of clinical trial experience in the pharmaceutical industry or within CROs.
- 2+ years of experience in managing a team of CRAs or similar clinical research roles.
- Experience of conducting real world evidence studies.
- Strong understanding of clinical trial planning (site) management and metrics.
- Recent and solid experience in a similar role at a CRO or pharma company.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Jack O'Neill at +44 203 846 0646 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.