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Clinical Project Manager

1 month ago

London, Greater London, United Kingdom Richmond Pharmacology Full time

Job Title: Clinical Project Manager Location: Hybrid (4 days onsite in London Bridge) Term: Permanent, Full-time Salary: Competitive Benefits (Private Medical, Private Dental, Pension, 25 days Annual leave plus bank holidays & Many more) Richmond Pharmacology is a leading Contract Research Organisation (CRO) specialising in early-phase clinical trials for pharmaceutical and biotechnology sponsors. With a commitment to excellence and innovation, we strive to advance medical research and contribute to the development of life-changing therapies. The Role: The Clinical Project Manager is responsible for managing the trial from set-up through to the clinical and post-clinical phases, overseeing the operational delivery of our clinical trials. This involves coordinating the activities of cross-functional teams and closely interfacing with internal departments and external stakeholders to ensure the highest level of output from each trial. The CPM is held accountable for achieving the successful delivery of budgeted activities at the project level, adhering to company and regulatory requirements within specified time, quality/scope, and budget constraints. They must ensure that the trials are conducted in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and other local regulatory requirements. Main duties and responsibilities To perform, manage, and coordinate the setup and running of clinical trials in accordance with the protocol, Richmond SOPs, GCP, and all relevant guidelines. Acting as the main point of contact for sponsors, vendors, and the wider project team. Provide regular study updates to internal teams as well as stakeholders, including trial sponsors. Reviewing proposed study protocols to evaluate factors such as, but not limited to, sample collection processes, data management plans, and potential subject risks. Escalating protocol risks to the principal investigator and sponsors and assisting in risk mitigation. Compilation of study documentation such as Study Operations Manual (SOM) & master treatment schedule, review of protocol & Informed Consent Form (ICF), staff training & delegation, green light sign-off, and maintaining the Master Study File (MSF). The management of external vendors such as central/local laboratories or external consultants. Independently preparing for and attending green light sign-off (GLSO) meetings and other meetings with the PI. Oversight of regulatory compliance and training. Prepare for or participate in quality assurance audits or inspections conducted by study sponsors, CRO, or regulatory. Additional responsibilities Prepare and coordinate flow of all study documents, ahead of study initiation. Effectively coordinates cross-functional teams from study set-up to clinic to post clinical phases for timely and quality delivery to clients. Ability to independently address sponsor operational comments effectively Qualifications and Experience: BSc in Life Sciences (or equivalent); or other clinical research academic qualification. - Project Management (or equivalent) academic qualification Minimum 2 years previous experience in a similar role. Experience in a clinical research environment. Competency in GCP and strong interest in clinical research. - Previous experience with Phase 1,2 and 3 studies essential. - Monitoring or co-monitoring experience preferable. Co-monitoring experience. - Experience with technical, scientific and medical information. Understanding of clinical budgets. Demonstrate an understanding of confidentiality issues. Demonstrate an understanding of clinical study protocols. - Experience in GLSO processes and pro Application: If you are interested in the role, please register your details, including a copy of your CV. Please note, while we try to respond to every candidate, the high volume of applications anticipated may make this impossible and we ask for your patience and understanding.