Sr. CPM
700 Saginaw Drive Redwood City, CA 94043 US
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.
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Adhere to Clinical Standard Operating Procedures (SOP), Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) Guidelines.
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Be a team leader, providing guidance and oversight for the successful management of all aspects of clinical trials within timelines and designated program budgets.
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Partner with cross-functional teams to manage, adjust, and revise project timelines and budgets as needed.
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Analyze data health metrics to be shared with stakeholders.
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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.
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Conduct risk management, contingency, and scenario planning.
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Supervise, communicate project status/issues, and problem solve to ensure project team goals are met.
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Participate in the development of all study-related documentation, including study protocols.
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Actively contributes in the selection and management of contract research organizations (CROs) and/or vendors, including development of requests for proposals (RFPs).
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Use all available tools to track, oversee, and communicate on program status to all key stakeholders.
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Participate in other Clinical Operations activities as appropriate.
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Leads a larger, more complex trial with some oversight from senior members of Clinical Operations.
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With minimal support, lead cross-functional Clinical Study Execution Team (CSETs).
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Participate in and contribute to SOP development, implementation, and training.
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Support junior team members through mentorship.
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Demonstrate the ability to lead and manage multiple complex clinical trials within one or multiple programs with limited oversight.
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Independently lead Clinical Study Execution Team (CSETs) and influence relevant stakeholders both internally and externally including management.
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May lead interdepartmental strategic business initiatives as well as spearhead certain SOP development and training.
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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.
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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:
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Bachelor’s, RN or Master’s degree in biological sciences or health-related field required.
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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.
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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.
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Strong working knowledge of FDA Regulations, ICH Guidelines, and GCP.
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Proven ability to successfully start-up, manage, and close-out clinical trials, including authoring clinical study and regulatory documentation and SOPs.
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Experience in selection of CROs/vendors and management of external resources.
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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.
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Be solution-oriented by anticipating obstacles and difficulties, and proactively providing risk assessment and mitigation strategies to achieve project goals.
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Excellent written/verbal communication and interpersonal skills.
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High sense of priority and commitment to excellence in the successful execution of deliverables.
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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.
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Demonstrate proficiency in Microsoft Office Suite (Outlook, MS Word, Excel, PowerPoint); MS Project and/or Smartsheet a plus.
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Travel may be required (~25%).
Preferred Skills:
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Familiarity working with vendor systems/portals (e.g., eTMF, EDC, IRT, CTMS).
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Oncology experience, early and/or late stage, strongly preferred.
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Knowledge and/or familiarity with Ex-US region(s) clinical trial operations.
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Some experience managing direct reports(s) for Sr. CPM role and mentoring experience for CPM.
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