Manager, Clinical Affairs/Research (Leesburg, VA OR Allendale, NJ) in Leesburg, VA at Stryker Corporation

Date Posted: 11/7/2019

Job Snapshot

Job Description

Who we want

  • Goal-oriented orchestrators. People who can effectively coordinate and focus the work of skilled employees toward an important goal, prioritizing to the right activities that lead to success.
  • Metrics-oriented managers. People who are always tracking important business metrics to ensure projects meet expectations and budget
  • Accuracy-oriented team leaders. Providing direct oversight of processes and results, managers who ensure accurate and timely completion of projections, forecasts or reporting.
  • Subject matter experts. Managers who not only oversee the collection, review, and analysis of data but can interpret, translate, and present on all various matters as needed.
  • Talent developers. Growth-oriented managers who recruit and hire top-performing talent and prioritize the development of their team members.
  • Network builders. Managers who build connections with other teams and divisions and coordinate cross-functional collaboration.

What you will do

As a Manager, Clinical Affairs, you will have overall management responsibility for IDE and post-marketing clinical trials including management of clinical personnel and participation in budget and resource allocation to various projects. You will ensure all clinical research activities are conducted in accordance with Good Clinical Practices and all relevant regulations, policies and procedures.

Essential Duties & Responsibilities include:

  • Recruit, hire, train, manage Clinical staff and their career development
  • Select Clinical consultants and Clinical Research Organizations (CROs) and manage their contracts
  • Prepare and track Clinical budget
  • Allocate resources and budgets to various department projects and oversee their progress
  • Participate in preparation of Clinical operating plans and objectives in alignment with company and department strategies
  • Supervise the implementation of clinical programs and track their progress
  • Oversee the planning of new clinical programs and the development of clinical protocols
  • Review and approve submissions of protocols and reports to the relevant regulatory authorities and Institutional Review Boards (IRBs) or Ethics Committees (ECs)
  • Interact with Investigators and IRBs on financial and compliance issues
  • Oversee the proper collection, analysis and presentation of clinical data
  • Review and approve final Case Report Forms, Edit Checks and Clinical Study Databases
  • Oversee development and maintenance of department SOPs
  • Assure compliance of department activities to the relevant regulations, department SOPs, and corporate requirements
  • Develop and manage the process for clinical regulatory document preparation and submissions for clinical studies (IDE submissions, IRB/EC submissions, etc.)
  • May also author, oversee and/or review Clinical Evaluation Plans, Clinical Evaluation Reports, Post Market Clinical Follow Up plans and reports, SSCPs and any other clinical documentation required for continued CE Marking.

What you need

  • Bachelor’s degree; Focus in science or health-related field such as Biology, Nursing or Biomedical Sciences preferred
  • 5+ years clinical experience required
  • Experience conducting Investigational Device Exemption (IDE) and post-marketing clinical trials of medical devices strongly preferred
  • Prior people management experience
  • Experience in submission of IDEs, Post Marketing Applications (PMAs) to the Food and Drug Administration (FDA) agency, as well as meetings with FDA
  • Experience developing, optimizing and maintaining department Standard Operational Procedures (SOPs)
  • Strong knowledge of FDA regulations and International Conference Harmonization (ICH) Good Clinical Practices (GCPs) guidelines
  • Demonstrated experience with European clinical study requirements and CE marking, EU MDD / MDR, MEDDEV 2.7.1 Revision 4, ISO 14155 and other relevant regulations
  • Strong leadership skills
  • Experience in team based work environment - Must be able to interact effectively with all levels of management including other functions internally and externally such as other Stryker Divisions and Stryker Corporate

You may also have

  • Advanced degree
  • ACRP or SoCRA Certification

Work From Home: Occasional

Travel Percentage: 20%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

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