Local Study Associate Director (FSP)

Some specifics about this role:

You will be leading the Local Study Team(s) (LSTs) at country level in the capacity of Local Study Associate Director (LSAD) at our sponsor’s organization, providing support and advice on the process of clinical trials and studies as an expert or through the supervision of a local or global team. Committed to delivering components of clinical studies according to agreed resources, budget and timelines complying with sponsor’s procedural documents, ICH-GCP as well as relevant local regulations. Be the recognized expert within own field and often first point of contact for related queries and provide process support as an expert or project manager supervising a range of projects. In addition to leading LST(s), the LSAD may perform site monitoring as needed to support the flexible capacity model. Responsible for ensuring sites are identified, site qualifications performed, set-up, initiated, monitored, closed and documentation archived.

What we look for in: Bachelor’s 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). 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 knowledge of spoken and written English . Excellent project management skills (Minimum 2 years of PM experience). Excellent team-building, negotiation, organizational, communications (written/verbal) and interpersonal skills. Meticulous and demonstrate excellent ability to prioritize and handle multiple tasks.

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