Senior Clinical Program Manager, Clinical Operations

The Opportunity:

• 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.

• Conduct risk management, contingency, and scenario planning.

• Supervise, communicate project status/issues, and problem solve to ensure project team goals are met. 

• Participate in the development of all study-related documentation, including study protocols.

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

• Use all available tools to track, oversee, and communicate on program status to all key stakeholders.

• Demonstrate the ability to lead and manage multiple complex clinical trials within one or multiple programs with limited oversight.

• Independently lead Clinical Study Execution Team (CSETs) and influence relevant stakeholders both internally and externally including management.

• May lead interdepartmental strategic business initiatives as well as spearhead certain SOP development and training.

• May provide input into strategic and operational short- and long-term therapeutic area development, as appropriate, including supporting alignment and communication to other team members upon implementation.

• Assists in the hiring, development, and retention of top talent within the team. Coach direct report(s) on their performance, development, and career interests.

• Participate in other Clinical Operations activities as appropriate.

Required Skills, Experience and Education:

• RN or Bachelor’s or Masters degree in biological sciences or health-related field required.

• 10+ years direct Clinical Operations experience in the pharmaceutical or biotech industry, preferably in Clinical Operations or Clinical Research-related experience. Relevant indirect experiences may also meet the requirement.

• 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.

• Be solution-oriented by anticipating obstacles and difficulties, and proactively providing risk assessment and mitigation strategies to achieve project goals.

• Excellent written/verbal communication and interpersonal skills.

• High sense of priority and commitment to excellence in the successful execution of deliverables.

• Ability to analyze operational data, contribute with a mind on quality, timeliness and fiscal responsibility, make and drive decisions, multi-task, prioritize tasks, anticipate challenges, and execute on goals as a member of an interdisciplinary team.

• Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.

• Travel may be required (~25%).

Preferred Skills, Experience and Education:

• Familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).

• Oncology experience, early and/or late stage, strongly preferred.

• Knowledge and/or familiarity with Ex-US region(s) clinical trial operations.

• Some experience managing direct reports.

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