To lead Local Study Team at country level (Malaysia) to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with sponsor's Procedural Documents, international guidelines such as ICH-GCP as well as relevant local regulations. The Clinical Lead may perform site monitoring as needed to support the flexible capacity model. The Clinical Lead is responsible to ensure that sites are identified, site qualifications performed, set up, initiated, monitored, closed and documentation archived.

Responsibilities

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 sponsor's 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.
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 Director, SMM/ Director, Country Head.
Ensures timely preparation of local Master CSA (including site budget) and amendments as needed.
Ensures that all study documents are ready for final archiving and completion of local part of the eTMF.
Plans and leads activities associated with audits and regulatory inspections in liaison with CQAD and QA.

Requirements

Bachelor degree in related discipline, preferably in life science, or equivalent qualification
Minimum 3 years of experience in Development Operations (CRA, SrCRA) or other related fields (Medical Affairs-led or Academic-led studies).
Good knowledge of international guidelines ICH-GCP as well as relevant local regulations.
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.
Excellent team building and interpersonal skills.
Excellent organisational skills.
Excellent verbal and written communication skills.
Excellent ability to prioritize and handle multiple tasks.

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Clinical Lead/Local Trial Manager