Senior Clinical Study Manager (Remote) - Virginia DC Surrounding, Virtual Address

Work Flexibility: Remote

Stryker is seeking to hire a Senior Clinical Study Manager (Remote) to join our Spine Division. As a Senior Clinical Study Manager, you will assume overall responsibility for executing on the clinical evidence strategy for medical devices and support the development of this strategy. This may include creating and executing clinical regulatory strategies in support of new and continued global market access.

WHO WE WANT:

• Self-directed initiators.  People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities. 

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.

• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations. 

What you will do:

• Propose best practices in conduct of clinical studies, ensuring alignment to Good Clinical Practice (GCP).
• Manage ongoing Investigator-Initiated Studies and/or Stryker-Initiated Studies (as applicable).

• Responsible for all aspects of clinical research including preparation, study design, execution, and reporting. Generate clinical data for the business in alignment with the strategy.

• Contribute to trial synopsis, protocol, and amendments to ensure operational feasibility; contribute to defining the Case Report Form content; develop study-specific procedures, contribute to the monitoring plan and other operational documents.

• Partner with stakeholders to develop clinical evidence strategies for the short- and long-term. Provide clinical and scientific expertise to influence business strategy and drive informed planning and decision-making.

• Create and execute clinical regulatory strategies for new and continued global market access. Author clinical portions of regulatory submissions (e.g., protocols, investigator’s brochures).

• Participate on NPD teams, as required. Support claims development, especially those requiring clinical data to substantiate.

• Coordinate and support field-monitoring activities; maintain monthly study highlights (including enrollment curves and timelines) in a timely manner.

• Work with trial project teams to assess project risks and issues.

• Understand project deliverables and achievement of deliverables.

• Communicate with the team on changes in project, policy, and priorities.

• Responsible for working with health registries and large databases

• Work in compliance with clinical processes, regulations, and data management

• Ability to work independently on multiple projects with ability to prioritize tasks

• Responsible for initiating and managing research contracts for Investigator Initiated Studies (if applicable)

• Responsible for driving study results to be published in peer-reviewed journals

• Presents study results/updates to various internal stakeholders cross-functionally, as needed.

• Provide budget input aligned to planned clinical strategy for clinical studies and clinical evaluations.

• Act as Stryker liaison and build partnerships with clinical research organizations (CROs), data management vendors, medical writers, and other external parties to ensure robust and scalable clinical study and clinical evaluation support.

• Review and approve collateral material for the Clinical Affairs function.

• Support the development and maintenance of procedures to ensure effective management of clinical studies and clinical evaluations.

• Lead cross-functional initiatives and participate in departmental process improvement initiatives.

What you need

Required

• Bachelor's level degree required; preferably in a science or health care field with at least 6 years of clinical research experience, preferred in clinical study management.

• Fundamental knowledge and a good understanding of GCPs, clinical trial design, study development, and project management.

• Demonstrated interpersonal, written, and oral communication skills as well as excellent organizational and time management skills in a fast-paced environment.

Preferred

• Candidates with medical device experience strongly preferred.

• Possess deep knowledge of post market clinical follow up and clinical data requirements as defined by EU MDR. 

• Preferred clinical research or project management certification (e.g., CCRP, ACRP, PMP)

98,000.00 to 210,100.00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

Travel Percentage: 10%

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.