Local Study Manager
CK Group is recruiting for a Local Study Manager to join a company in the Pharmaceutical industry at their site based in Luton on a contract basis for 12 months.
Our client is a global pharmaceutical company with a large presence and multiple sites in the UK. They produce innovative medicines across a range of therapeutic areas to enhance the health and lives of their patients.
Luton is a large town in the South East of England located 32 miles north of London. It is close to Luton airport which flies to many European destinations. It has three train stations with direct trains from London St Pancras and is close to the M1 motorway.
The Role: This vacancy is within the Oncology TA so the candidate must have experience in working on Oncology trials.
To lead Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with company Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations.
- Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
- Leads Local Study Team consisting of CRA(s), CSA(s), for assigned study/studies.
- Leads and optimises the performance of the Local Study Team(s) at country level ensuring compliance with comProcedural Documents, ICH-GCP and local regulations.
- Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
- Coordinates 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.
- Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study. Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
- Ensures timely preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in clinical studies financial system by regular checks of the system and financial reports (as agreed with ADSMM/CH).
- Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
- Ensures timely preparation of country level Master Informed Consent Form (MICF) and subsequent site level ICFs, as required, including any relevant translations, and in line with relevant SOPs and local regulations.
- Ensures 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, and in line with SOPs.
- Plans and coordinates applicable local drug activities (from local purchase or reimbursement to drug destruction).
- Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
- Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
- Reviews monitoring visit reports (as required and following SOPs) and pro-actively advices the monitor(s) on study related matters.
- Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
- Bachelors degree in related discipline, preferably in life science, or equivalent qualification (*).
- Experience in Development Operations (CRA, Sr CRA) is essential.
- Excellent project management skills and experience as a project manager managing trials within UK or globally.
- Proven ability to lead and motivate cross-functional teams to deliver clinical trials according to or ahead of time plan, budget and with required quality.
- Excellent ability to prioritize and handle multiple tasks.
For more information or to apply for this position, please contact Natasha on 01246 457739 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and 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 47047 in all correspondence.