Senior Clinical Trial Manager

Qualifications: * The ideal candidate will have a degree in life sciences. Advance degree preferred. * Minimum of 5 yrs in the Pharmaceutical industry with experience in global drug development OR strong clinical experience with IND/NDA preparation, protocol writing and Study Report Review. Experience reviewing data management plans and statistical analysis plans preferred. Demonstrated knowledge of GCP/ICH requirements. * Ability to work independently * Strong interpersonal skills * Demonstrated excellence in oral and written communications. * Able to operate in a Team environment/Matrix organization. Responsibilities: * Accountable for all aspects of clinical studies (Phases 1-4). Review and approve study documents. Collaborate with Medical Directors, Marketing, Legal and Regulatory Affairs to design clinical programs for OTC products. * Evaluate potential vendors, negotiate budgets, and finalize contracts. Manage multiple clinical studies according to GCPs, SOPs, protocol and local regulations. * Serve as the primary contact for CRO and/or sites. * Review and approve ICFs, CRFs, SAP, DMP, edit checks and clinical study reports. * Contribute to the writing of clinical sections of INDs, NDAs, and IBs. * Ability to work in a fast paced timeline oriented environment required. * Knowledge of study management and data interpretation is desirable, as are project management, organization, interpersonal, problem solving and communication skills. * The ability to work both independently and in a matrix system is essential.

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