Clinical Trials Manager
Lucy Stendall at CK Clinical is recruiting for a Clinical Trials Manager to join a leading, multi-speciality health care company, on a full time, contract basis for 12 months in the first instance. This role will be working on Phase III outsourced medical devices studies.
As a Clinical Trials Manager you will ensure that clinical strategies are translated into operational plans and executed in line with clinical development plans. In particular, you will align operational execution activities with agreed upon project priorities, timings and quality specifications and adhere to all relevant regulations including GCP, ICH and PhRMA guidelines, Regulatory requirements, and company SOPs and policies.
Key Accountabilities/Responsibilities of a Clinical Trials Manager will include:
- Study management aspects of a global clinical study including but not limited to all of the tasks specified below. For all of the global study activities, the incumbent will work with the Regional Study Managers (RSM) to ensure correlation of global study activities.
- Ensuring global study feasibility in collaboration with RSMs (if global study) and summarize regional allocation of patients and resource; initial assessment of vendors needed; and the development of study timelines.
- Global essential document development (e.g. study level consent forms, advertising materials), and study deviation specifications; assessing global vendor requirements and liaising with appropriate departments on vendor selection; ensuring the development of global enrolment initiatives and budgetary planning; planning clinical study supplies; review and approval of data management plan.
- Global IMP supply; study enrolment management/tracking (e.g. contingency planning and implementation); global vendor management; global budgetary management; trial master file oversight; ongoing management of protocol deviations; ongoing review of study data and data cleaning process.
- Reviewing of CSR shells; reviewing of CSR and assembly of appendices; database lock activities; finalization of the study protocol deviations repository; ensuring that the study close out activities are completed; ensuring study documentation is properly archived.
As a Clinical Trials Manager, you will have the following qualifications, skills and experience:
- Science Degree with significant pharmaceutical industry or clinical development/medicine experience
- Experience of site monitoring and study management responsibility is required.
- Thorough understanding of ICH Good Clinical Practices, Clinical Safety Data Management, clinical trials management (including site monitoring), regulatory compliance (including individual global/country directives/regulations as necessary) and statistical reporting including demonstrated, ongoing application of these knowledge domains to current studies for which the CTM is responsible.
- Knowledge of scientific methods, research design, and medical practices and procedures that would be acquired through experience with human medical research.
For more information or to apply for this Clinical Trials Manager position please contact Lucy Stendall on 01246 457733 or email email@example.com Alternatively, please click on the link to apply online now.
CK Clinical is an Equal Opportunities employer who welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference CL35095 in all correspondence.