Contract Clinical Study Manager
A global biopharmaceutical company is advertising a vacancy for a Contract Clinical Study Manager. The organisation focuses on developing treatments in the fields of oncology, cardiovascular & metabolic disease (CVMD), and respiratory fields, as well as actively participating in the fields of autoimmunity and infection. This position offers an exciting opportunity to work with an innovative company's UK office for a 12 month contract.
- Overseeing study commitments within the country and for timely delivery of data to required quality.
- Leading Local Study Team consisting of CRA(s) and CSA(s) for assigned study/studies.
- Leading and optimising the performance of the Local Study Team(s) at country level, ensuring compliance with company Procedural Documents, ICH-GCP, and local regulations.
- Ensuring, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
- Coordinating the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
- Ensuring the timely submission of application/documents to EC/IRB at start up and for the duration of the study.
- Working together with Regulatory Affairs to ensure the timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study that are in line with local regulations.
- Ensuring the timely preparation of country financial Study Management Agreement (fSMA) and maintaining accurate study budgets in the company's clinical studies financial system by making regular checks of the system and financial reports (as agreed with ADSMM/CH).
- Ensuring the timely preparation of local Master CSA (including site budget) and amendments as needed.
- Ensuring the timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, including any relevant translations, and guaranteeing that they comply with relevant company SOPs and local regulations.
- Ensuring that all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enrol.
- Planning and coordinating applicable local drug activities (from local purchase or reimbursement to drug destruction).
- Setting up and maintaining the study in CTMS at study country level as well as local websites as required by local laws and regulations.
- Overseeing, managing, and coordinating monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
- Reviewing monitoring visit reports (as required and following company SOPs) and pro-actively advising the monitor(s) on study related matters.
- Performing any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
- Organising regular Local Study Team meetings on an agenda driven basis.
- Actively working towards achieving good personal relationships with all Local Study Team members, sites' staff, and global stakeholders.
- Reporting study progress/updates to the Global Study Leader/ Global Study Team, including SMM Lead.
- Contributing to the company's patient recruitment strategy, including carrying out regular communication with participating Investigators, as necessary.
- Developing, maintaining, and reviewing risk management plans on country study level: proactively managing sites, stakeholders, local and global vendors, and customers to ensure risks are timely identified, mitigated, and managed.
- Ensuring that relevant systems required to facilitate business critical or license-to-operate activities (for example, Safety Reporting, Regulatory submissions, and Clinical Trial Transparency) are set-up, updated, and access is organised at country level.
- Ensuring accurate payments related to the study are made according to local regulations and agreements.
- Training and coaching new members of the Local Study Team, ensuring compliance with ICH-GCP and company Procedural Documents.
Skills and Requirements:
- A minimum of 3 years of experience in Development Operations (CRA, Sr CRA).
- Demonstrable experience as a project manager managing trials within the UK or globally.
- 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 Matthew Pike at +44 207 440 0639 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.