Sr. CPM Job at Planet Group, Saginaw, MI

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  • Planet Group
  • Saginaw, MI

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,

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