Clinical Affairs Manager

Clinical Affairs Manager

5-8 years
Not Specified

Job Description

POSITION TITLE: Clinical Affairs Manager REPORTS TO: Clinical Study Manager
FUNCTION: Clinical Affairs Manager leads in the planning and execution of a portfolio of clinical research programs while adhering to budget, scope and business timelines.
Clinical Affairs Manager collaborates across businesses and across regions as they lead efforts in planning and communication with cross-functional teams and external partners (investigators, contract laboratories, CRO SMO staff) to ensure proper project planning and execution.Clinical Affairs Manager will ensure compliance to applicable regulatory requirements, industry standards, and company policies & SOPs.
The primary responsibilities for the Clinical Affairs Manager include:
  • Plan, implement and manage clinical trials and influences study design and interprets results. Define clinical trial protocols, standard operating procedures (SOPs) and case report forms (CRFs) for use in clinical trials operations.
  • Develop clinical validation strategies, clinical study plans, and clinical protocols to evaluate safety and clinical efficacy aspects of products concept/prototype prior to product release. Manage the budget for projects and recommending resources to support projects, effectively drives action plan deliverables to OTD
  • Be responsible formultiple product lines for project management and registration purposeclinical trial quality control, give leadership for team members for clinical trial development. Give co-monitoring and trial quality control for CRA to ensure that clinical trials meet requirement of NMPA
  • Organize and manage clinical trial investigator meetings for responsible projects
  • Keep effective communication cross functionally and geographically.
  • Set up new clinical sites for responsible clinical trials, keep good relationship with investigators, KOLs
  • Good interface with government agency, cultivate relationship with vendors, consultants, contractors and professional associations, engage in NMPA consultation, be clear with NMPA regulation and IVD clinical trial requirement.
  • Drive clinical evidence strategy for multiple projects (including leveraging oversea clinical data for local regulatory submission)
  • Drives sustainment & improvement of functional standard work
  • Oversea data submission
  • Lead and Identify the appropriate DBS tools to solve complex issues, utilize DBS to drive process improvement (i.e. creating SW, leading Kaizen, leading DM, leading PSP), manage risks, and propose the appropriate countermeasures

This description is a summary of principle responsibilities and is not intended to include all duties may be assigned.
  • Education: BS/BA, Masters degree preferred
  • Experience: Candidates should have 7 years relevant work experience with BS degree, or 5 years of experience with MS or PhD. Prior demonstrated experience in the successful design/execution of premarket clinical research studies is highly preferred.
  • Business travel: Ability to travel (20-35% Domestic and/or international), and participation in professional activities outside of normal business hours

  • The candidate must possess highly effective interpersonal skills enabling them to lead clinical projects through negotiation and collaboration, have a strong understanding of clinical studies including GCP guidelines and applicable regulatory requirements, and display both flexibility and integrity.
  • The ideal candidate should also be well organized and detail oriented, have strong written and verbal communication skills, be highly proficient in MS Office (Word, Excel, Power point), and have the ability to multi-task and work effectively in a team or independently on assigned tasks.

When you join us, you'll also be joining Danaher's global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful tools and the stability of a tested organization.

At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

If you've ever wondered what's within you, there's no better time to find out.

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