Position summary:

• Responsible for the day-to-day management of one or more clinical studies, to include pre-market, post-approval, post-market surveillance, feasibility and/or marketing studies, and/or investigator initiated studies.

• Responsible for ensuring that assigned studies are being conducted in accordance with GCPs, NMPA regulations and department Standard Operational Procedures.

• Responsible for the on-time delivery of project results while ​​adhering to or surpassing​​ the quality and compliance requirements.

Essential Duties & Responsibilities: (Detailed Description)

• 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.

• Contribute to system testing as required (e.g. UAT for eCRF screens, database structure, data loading). Ensure proper collection and validation of data and documentation in a timely manner.

• Communicate to teams regarding monitoring activities, data flow, and data validation / cleaning; perform patient data validation homogeneously and fulfill required quality standard; ensure study documentation is properly maintained and archived in the Trial Master File.

• 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 team on changes in project, policy, and priorities.

• Responsible to work 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).

• Support the development and execution of strategies to obtain information and support concerning medical devices undergoing clinical investigation, post market surveillance or marketed/product use evaluation.

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

• Manage ongoing Investigator-Initiated Studies and/or Stryker Initiated Studies (as applicable).

• Set and manage deliverables for contracts to align with research strategy.

• Develop and maintain overall dashboard of clinical and non-clinical studies, including major milestones, objectives, and financial aspects.

• Support pre-clinical studies and develop non-clinical studies protocols to support existing products or investigate new products with cross functional support (if applicable).

• Work with internal and external resources to facilitate publication of study results in peer-reviewed journals.

• Partner with Legal and Finance team to ensure researchers are reimbursed in compliance with their contracts, as well as company’s compliance requirements.

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

• Responsible for achieving the study goals on a monthly, quarterly, and annual basis.

• Monitor and maintain the project metrics to meet or exceed the quality and compliance requirements.

Education & Experience:

• Bachelor's level degree or equivalent in science or healthcare field with at least 4 years of relevant clinical research experience, preferred in clinical study management.

• Preferred at least 2 years’ experience in clinical study monitoring.

• Preferred experience in Device or Pharmaceutical industry.

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

• Fluent in both verbal and written English is needed (CET-6 or equivalent minimum).

• Demonstrated ability to work effectively and collaboratively with internal stakeholders (Regulatory, Marketing, R&D, etc.) and external stakeholders (Physicians, CROs, etc.)

Other Requirements:

• Demonstrated success in assisting in solving complex strategies across multiple functions within the department in support of conducting multiple global clinical trials across multiple franchises.

• Demonstrated understanding of laws, regulations, standards, and guidance governing the conduct of clinical studies, as well as preparation of clinical documentation in support of regulatory submissions.

• Proactive, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships with stakeholders.

• Analytical, strategic thinker with leadership ability and style that demonstrates professionalism and establishes respect.

• Strong teamwork and collaboration skills, with the ability to minimize conflicts and foster a cohesive study team.

• Strong communication and presentation skills (articulate and persuasive), with the ability to gain stakeholders’ support accordingly

• Strong organizational and project management skills with a high sense of attention to detail.

• Strong interpersonal, organization, and planning skills to integrate study team towards study goals.

• Resilience and accountability to ensure project excellence and project delivery, and mitigate study risks and issues successfully

Leadership (People Management requirement)

People management experience is not required.