Provide statistical input into Protocol and CRF development

Design the randomization process for clinical studies

Communicate with clients regarding study protocol and statistical analysis

Review statistical analysis plans and provide input

Provide input to SOPs, general standardization efforts

Collaborate effectively with team members (internal and external)

Perform full quality control of all data received from external statisticians to assure 100% quality.

Assume primary accountability for assigned clinical research projects and ensures compliance with applicable regulations, guidelines, and corporate policies for study activities.

Manage and execute the overall project scope, budget, and timelines.

Ensure the appropriate development of all documents by CROs including but not limited to study documents, including informed consent forms, case report forms and instructions, site selection materials, investigator updates, and other project-specific documents required for the conduct of assigned studies.

Ensure that all project tasks meet client expectations and are completed in accordance with the contract, trial protocol, and Standard Operating Procedures (SOPs).

Serve as a liaison between clients and internal team to ensure project specific information and ongoing updates are proactively communicated.

Support the management and oversight of CROs and other clinical study related vendors.

Provide therapeutic training and guidance to the clinical team.

Enhance department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.