Study Delivery Manager

Where

King of Prussia, PA

What you'll be doing

Study delivery manager will lead and direct staff by providing company vision and strategy clear objectives, expectations and feedback on performance and opportunities for development, coach and keep staff motivated during heavy workload and changing priorities. Ensure appropriate level of resources of qualified and trained SDM and PA to support study delivery and to delivery of human subject research studies within deadlines and budgets according to ICH/GCP and company regulatory requirements. Recruit, retain, lead, and develop a team of SDM and PA, supporting study delivery. Decide upon appropriate allocation of SDM and PA to clinical projects/studies to reflect business and development needs in collaboration with project delivery lead (PDL) and head project delivery. Establish SDM and PA performance measurement, track performance, and identify corrective actions. Promote sharing of best practices. Ensure harmonization of practice at study level for study delivery managers to ensure consistency, high quality, and efficiency. Drive the implementation of new practices and best practice sharing.

What your background should be

Minimum 8 to 10 years of significant experience in managing clinical operations with strong knowledge of ICH/GCP and regulatory requirements driving clinical development required. Experience in people management and management of resources from different sources in different locations (internal, external, functional service providers) is an asset. Excellent knowledge and understanding of clinical operations and activities associated to study delivery. Excellent knowledge ICH-GCP and regulations, and written & spoken English, knowledge of French is an asset. Knowledge of industry and CRO world.

Required Schooling / Training

Master degree in pharmacy, chemistry, and bio engineer, biology, or bio medical sciences.

Who is the client company

The company provides pharmaceutical, biologics, vaccines and consumer healthcare services.

If you are interested in this position, send your resume to apply@kochdavis.com