Job Description
Senior Clinical Program Manager
The Opportunity: This is a unique opportunity for a Clinical Operations Professional. As a Temp Senior Clinical Program Manager (Sr. CPM), you will be responsible for acting as a central contact for the Clinical Study Team(s) and assist with the execution and management 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.
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. Coaches direct report(s) on their performance, development, and career interests.
Required Skills, Experience and Education:
Bachelor’s, RN or Master’s degree in biological sciences or health-related field required.
8+ years (CPM) or 10+ years (Sr. CPM) 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 (CPM) or minimum of 6 years (Sr. CPM) 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 managing direct reports(s) for Sr. CPM role and mentoring experience for CPM.
Job Tags
Remote job, Contract work, Temporary work, Work at office,