Clinical Program Assistant Jobs (NOW HIRING)

The Opportunity:

This is a unique opportunity for a Clinical Operations Professional. As a Clinical Program Manager (CPM), you will be responsible for acting as a central contact for the Clinical Study Team(s) and assist with the execution and management of Revolution Medicines (RevMed) clinical trials.

• 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 contributes 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.

• Participate in other Clinical Operations activities as appropriate.

• Leads a larger, more complex trial with some oversight from senior members of Clinical Operations.

• With minimal support, lead cross-functional Clinical Study Execution Team (CSETs).

• Participate in and contribute to SOP development, implementation, and training.

• Support junior team members through mentorship.

Required Skills, Experience and Education:

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

• 8+ 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 4 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:

• 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 mentoring jr staff. 

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