Senior Clinical Program Manager

10+ years direct Clinical Operations experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience.

Minimum of 6 years of cross-functional study management or related leadership experience in life sciences, including multiple years’ experience managing project teams.

Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.

Proven ability to successfully start-up, manage, and close-out clinical trials, including authoring clinical study and regulatory documentation and SOPs.

Experience in selection of CROs/vendors and management of external resources.

Thrives in a collaborative team setting that demonstrates flexibility required to maintain a fast pace and is driven by a desire to deploy innovative approaches and technologies in a high-energy environment.

Adhere to Clinical Standard Operating Procedures (SOP), Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.

Be a team leader, providing guidance and oversight for the successful management of all aspects of clinical trials within timelines and designated program budgets.

Partner with cross-functional teams to manage, adjust, and revise project timelines and budgets as needed.

Analyze data health metrics to be shared with stakeholders.

Actively partner with cross-functional teams and vendors to drive the query resolution and data listings review process to meet objectives in a timely and efficient process.

Actively contribute in the selection and management of contract research organizations (CROs) and/or vendors, including development of requests for proposals (RFPs).