Sr. CPM

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.