LOCAL STUDY ASSOCIATE DIRECTOR
PRA Health Sciences
Req #: 111711
Type: Germany
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Overview: As a Local Study Associate Director, you will be leading the Local Study Team(s) (LSTs) at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines complying with AZ Procedural Documents and international guidelines such as ICH-GCP as well as relevant local regulations. In addition to leading LST(s), as the Local Study Associate Director (LSAD) you may perform site monitoring as needed to support the flexible capacity model. Responsibilities: Key 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 CRAs, CTAs, and Study Start-up Specialists for assigned study/studies * Leads and optimizes the performance of the Local Study Team(s) at country level ensuring compliance with SOPs, 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 preparation of country financial Study Management Agreement (fSMA) and maintains accurate study budget in the clinical studies financial system by regular checks of the system and financial reports Qualifications: * Bachelor's degree in related discipline, preferably in life sciencqualification (*). * Minimum 3 years of experience in Development Operations (Crelated fields (Medical Affairs-led or Academic-led studies). * Good knowledge of international guidelines ICH-GCP as well regulations. * Proven ability to lead and motivate cross-functional teams to deaccording to or ahead of time plan, budget and with required qu * Excellent project management skills. * Excellent team building and interpersonal skills. * Excellent organizational skills. * Excellent verbal and written communication skills. * Excellent ability to prioritize and handle multiple tasks. * Excellent attention to details. * Excellent knowledge of spoken and written English. * Good negotiation skills. * Good ability to learn and to adapt to work with IT systems. * Ability to travel nationally and internationally as required.
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