Local Study Manager

Hobson Prior are looking for a Local Study Manager to join a world-wide biopharmaceutical organisation who are focused on improving the health of people globally through their broad research and development platform as well as a growing late-stage pipeline. You will be accountable to lead Local Study Teams at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines.

Job Responsibilities:

• Accountability for the study commitments within the country and for timely delivery of data to required quality.
• You will lead Local Study Teams consisting of CRAs, CSAs, for assigned study/studies
• 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.
• Leads and optimises the performance of the Local Study Teams at country level ensuring compliance with the organisations Procedural Documents, ICH-GCP and local regulations.
• Ensures, as required, that clinical and operational feasibility assessment of potential studies is performed to the highest quality.
• 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 and maintains accurate study budget in the organisations 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 and subsequent site level ICFs, as required, including any relevant translations.
• 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 the company's 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.

Key Skills:

• 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 project management skills.
• Strong team building and interpersonal skills.
• Excellent organisational skills.
• Ability to travel nationally and internationally as required.

Requirements:

• Bachelors degree in related discipline, preferably in life science, or equivalent qualification.
• Minimum 3 years of experience in Development Operations (CRA, Sr CRA) or other related fields (Medical Affairs-led or Academic-led studies).
• You will have good knowledge of international guidelines ICH-GCP as well as relevant local regulations.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.