We’ve an instantaneous place for a Clinical Program Management Leader with our direct shopper (Prime Pharmaceutical Firm) , in case you are please ship your up to date resume to nancy @ collabinfo.com or name me at 609-662-0262
Title: Clinical Program Management Leader
Location: Spring Home, PA
Period: 1 Yr Contract
- The CPML co-leads the Clinical Workforce the place the Clinical Leader drives technique and the CPML leads the workforce to operationalize that technique (together with state of affairs planning and setting priorities) to make sure all actions are aligned with the Compound Improvement Group objectives and goals. The CPML ensures documentation of medical group conferences, key selections and motion gadgets.
- Companions with medical chief and coordinates cross-useful leads (e.g. TA Clinical Improvement, GDOs, Clinical Provides, Finance, International Regulatory Affairs, International Medical Security) by way of groups and work streams designed to implement the medical program together with on the particular person trial degree to guarantee finish-to-finish trial oversight and to determine and mitigate points in an effort to keep high quality, timelines, assets and price range.
- Concerned within the protocol design (e.g. integrating content material for written paperwork and/or reviewing paperwork). Contributes to the evaluate of the medical research report and if relevant, coordinates the well timed availability of the medical research report appendices with the cross practical leads.
- Companions with the PML, Finance associate and useful results in forecast and handle the general medical price range on an ongoing foundation.
- In co-improvement packages, manages and aligns cross-firm medical analysis actions and goals.
- In collaboration with the medical and regulatory features, drives the planning and preparation of medical paperwork required for profitable Well being Authority submissions.
- Makes use of staff improvement greatest practices and facilitates classes discovered to make sure optimum efficiency of the Clinical Workforce.
- Organizes the content material of clinically-associated exterior committees and conferences similar to Advisory Boards.
Main duties embrace: Operations Management and Management; Clinical Program and Clinical Improvement Planning; Standing and Dashboard reporting, Submission (medical elements) planning duty; Program Info/Communication Management; Clinical Program Timeline Management, Danger identification and management, Clinical Useful resource demand and Finances Management; cross-useful communication & medical group management
Qualifications
B.S. diploma required. Superior diploma similar to MS, PharmD, or PhD diploma in Pharmaceutical, life sciences, or associated fields most popular. Skilled venture management certification (e.g. PMP) or Venture Management diploma is fascinating. 10 or extra years of business/enterprise expertise together with at the very least 7 years within the pharmaceutical business is required. At the least 5 years of medical drug improvement expertise in areas akin to Clinical Trials Management, Biostatistics, Medical Writing, Knowledge Management, Program Management or Regulatory is required. Immunology and/or pulmonary medical trial expertise fascinating. Expertise with Part 1-three medical packages is very fascinating. Demonstrated monitor document of cross-practical/matrix group management required; expertise in management of worldwide groups most popular.
Greatest Regards
Nancy Brown
Collab InfoTech / Collab Clinical
300 Carnegie Middle, Suite 150
Princeton | NJ | 08540
Contact: 609 662 0262
E mail: nancy @ collabinfo.com
Web site: www.collabinfo.com, www.collabclinical.com
LinkedIn: https://www.linkedin.com/in/nancybrowncollab
Job Sort: Contract
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