Sr. Manager, Clinical Inspection Readiness - Contract - Onsite
Proclinical Staffing is seeking a Sr. Manager, Clinical Inspection Readiness to join a cutting-edge biotech company. This is a contract role located in Basking Ridge, NJ.
Primary Responsibilities
The Temp Senior Manager, Clinical Study Inspection Readiness, is responsible for leading clinical inspection readiness activities to support the Program Operations Leader and Clinical Study Lead for one or more assigned clinical programs within Clinical Trial Management. The role is responsible for leadership, preparation, and organization for GCP inspections in accordance with ICH/GCP, Standard Operating Procedures (SOPs), Work Instructions (WI) and Business Practice Tools (BPT). This role will provide inspection readiness leadership to internally sourced studies and studies outsourced to Clinical Research Organizations (CROs) and serves as the key CTM inspection readiness point person for internal/external team members.
Skills & Requirements:
- Bachelor's degree and minimum of 8 years relevant industry experience.
- Experience with global agency inspections
- Extensive knowledge in research & development with experience in global clinical trial operations including experience developing protocols and key study documents
- Quality focused with effective project management skills, cross-functional team leadership and organizational skill
- Demonstrated interpersonal & leadership skills, with high degree of collaboration
- A data driven approach to planning, executing, and problem solving
- Effective communication skills via verbal, written and presentation abilities
- Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization
- Ability to influence and negotiate
- Technical proficiency in trial management systems and MS applications including (but not limited to) Project, PowerPoint, Word, Excel, IVRS/IWRS, EDC
The Sr. Manager, Clinical Inspection Readiness will:
- Serve as a key point of contact for CTM inspection readiness activities and point person for internal/external team members.
- Work with Clinical Study Team (CST) and functional areas to support CTM in providing responses to the Q&A sessions held by Inspection Management for Inspection Readiness, support action item follow up as needed.
- Support ongoing CTM activities related to TMF health and oversight
- Provide guidance on compliance and regulations and ensure CTM staff study teams are following targeted SOPs during study, Business Practice Tools and Working Instructions during the study
- Track inspection readiness meetings, CTM Inspection action items, questions and answers, storyboards, and presentation requests with key stakeholders (internal/CRO) until closure
- Support the CTM processes related to Inspection Readiness to ensure that appropriate documentation is produced/maintained in the TMF, including frequently requested documents and early identification of Sites of Interest (SOI).
- Work with the Clinical Study Leads, CRO and/or Vendor team(s) to obtain all the necessary essential and regulatory documents for all study/sites as part of the IRR activities with DRM.
- Track CTM action items assigned following inspections to ensure action plans are in place for remediation, as needed, with timelines for completion. Ensure supportive documentation is available to support resolution of the action items and provides updates to as needed on the resolution
- May lead and participate in internal process improvement projects/initiatives to continuously improve operational excellence to support inspection readiness
- May require up to 25% travel
Compensation:
$90 - $100 per hour
If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at (+1) 617-830-1769 or b.forsen@proclinical.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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