Temp Senior Clinical Program Manager, Compliance and Training

CPM), you will be in a key role in the Clinical Operations, Compliance and Training function in Client's Clinical Operations to support the development and continuous improvement of GCP infrastructure using knowledge and experience with clinical study management, clinical compliance, clinical quality, International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCP) and regulatory requirements. 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.

Title: Temp Senior Clinical Program Manager, Compliance and Training

Location: Local Hybrid or Remote

Contract: 6 Months

The Opportunity:

• This is a unique opportunity for a Clinical Operations Compliance Professional. As a Sr. Clinical Program Manager (Sr. CPM), you will be in a key role in the Clinical Operations, Compliance and Training function in Client's Clinical Operations to support the development and continuous improvement of GCP infrastructure using knowledge and experience with clinical study management, clinical compliance, clinical quality, International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCP) and regulatory requirements.
• Support Clinical Operations with GCP guidance and best industry practices.
• Lead or support the development and continuous improvement of Clinical Policies/ SOPs/ WIs/ Templates/etc. in compliance with International Conference on Harmonization (ICH) Guidelines, Good Clinical Practices (GCP) and regulatory requirements.
• Contribute to the management of business and compliance metrics to assess and continuously improve Client's oversight and inspection readiness throughout the clinical trial lifecycle.
• Support Clinical Operations Inspection Readiness activities.
• Contribute to Clinical Operations training programs to deliver Client's standards, GCP, and regulatory requirements.
• Partner cross-functionally and with QA on remediation plans and continuous improvement of GCP systems, investigations, CAPAs, and audit responses.
• Communicate deliverable status/issues, and problem solve to ensure functional goals are met.
• Use all available tools to track, oversee, and communicate on project status to all key stakeholders.
• Participate in other Clinical Operations Compliance & Training activities as assigned.

Required Skills, Experience and Education:

• RN or Bachelor's or Masters degree in biological sciences or health-related field required.
• 10+ years (Sr. CPM) direct Clinical Operations and/or Clinical Compliance and/or Clinical Quality Assurance experience in the pharmaceutical or biotech industry or Clinical Research-related experience.
• Strong working knowledge of FDA Regulations, GCP, and ICH Guidelines, current industry practices.
• Demonstrated experience successfully developing and authoring Clinical and cross-functional SOPs ensuring compliance with GCP and regulatory requirements.
• Experience with development and monitoring of oversight activities.
• 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:

• Oncology experience, early and/or late stage.
• Knowledge and/or familiarity with Ex-US region(s) regulations and requirements.