Position summary:

• Develops and executes clinical project plan including scope timeline, budget, resources, and risks.

• Responsible for the day-to-day management of one or more clinical studies.

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

• Interfaces with cross functional team (clinical, divisional, and external) and acts as Stryker liaison with site investigators and study coordinators. 

• Supports a large number of studies, or a limited number of the most complex studies under limited supervision. 

• Provides guidance and training to CSAs, CRAs etc.

• Responsible for the overall operational planning and activities for implementation and conduct of Clinical studies.

• Responsible for leading and managing diverse teams of clinical staff of clinical study management activities.

• Provide leadership and guidance to less experiences team members through reviewing their work and assisting in their training.

Essential Duties & Responsibilities: (Detailed Description)

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

• Facilitate development of trial synopsis and protocol, and develop project plan. Direct, manage, monitor and control project. Evaluate and decide tradeoffs within project. Facilitate preparation of clinical documents in support of regulatory requirements.

• 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. contribute to defining the Case Report Form content.

• 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 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 process, regulations and data management

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

• 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

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

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

• Partner with Legal and Finance team to ensure researchers are reimbursed in compliance with their contracts.

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

• Select and hire high quality staff; develop on-boarding processes; ensure staff has materials, systems, and training to fill job responsibilities.

• Lead clinical resourcing through continual evaluation of existing and future resource alternatives; initiate proactive planning and collaboration with leadership and operational peers.

• Evaluate quality of work for a variety of job roles and specialized functions; evaluate workload, quality and budget metrics through regular review and reporting of findings; collaborate with senior management and other functional leadership to improve efficiencies, project outcomes and quality metrics for clinical projects

• Work with project team to ensure high data quality in the trial using 2-3 quality planning tools and techniques. Monitor and maintain plans. Provide oversight to ensure patient safety.

• Lead or participate in departmental process improvement initiatives

• Manage staff in accordance with organization’s policies and applicable regulations

• 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

• Good teamwork and coaching skills

• May lead the development of new systems and procedures

• Plans, conducts, and supervises assignments

• Reviews progress and evaluate results

• Support continuous improvement activities

• Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these target

• Recruit, select, and on-board top talent

• Develop talent within team to increase performance

• Actively address performance issues on team

• Maintain a high level of team engagement

• Ability to lead a team to deliver results on multiple, simultaneous, complex projects.

Education & Experience:

• Bachelor's level degree or equivalent in science or healthcare field with at least 6 years of relevant clinical research experience, preferred in clinical study management.

• Preferred experience in Device or Pharmaceutical industry.

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

• Well organized and detail-oriented,  strong written and verbal communication skills

• 2-4 years project management experience in clinical studies

• 2-4 years monitoring experience in clinical studies

Other Requirements:

• Good verbal/written English skills

• Resilience and accountability to deliver project excellence with passion

• Experience in managing pre-market studies is a plus.

• Clinical study experience in an MNC or international CRO company is a plus

Leadership (People Management requirement)

People management experience is a plus, but not required.