Position summary:
61 Develops and executes clinical project plan including scope timeline, budget, resources, and risks.
61 Responsible for the day-to-day management of one or more clinical studies.
61 Responsible for ensuring that assigned studies are being conducted in accordance with GCPs, Local regulations and department Standard Operational Procedures.
61 Interfaces with cross functional team (clinical, divisional, and external) and acts as Stryker liaison with site investigators and study coordinators.
61 Supports a large number of studies, or a limited number of the most complex studies under limited supervision.
61 Provides guidance and training to CSAs, CRAs etc.
61 Responsible for the overall operational planning and activities for implementation and conduct of Clinical studies.
61 Responsible for leading and managing diverse teams of clinical staff of clinical study management activities.
61 Provide leadership and guidance to less experiences team members through reviewing their work and assisting in their training.
Essential Duties & Responsibilities: (Detailed Description)
61 Contribute to trial synopsis, protocol, and amendments to ensure operational feasibility; develop study-specific procedures, contribute to the monitoring plan and other operational documents.
61 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.
61 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.
61 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
61 Coordinate and support monitoring activities; maintain monthly study highlights (including enrollment curves and timelines) in a timely manner.
61 Work with trial project teams to assess project risks and issues.
61 Understand project deliverables and achievement of deliverables.
61 Communicate with team on changes in project, policy, and priorities.
61 Responsible to work with health registries and large databases
61 Work in compliance with clinical process, regulations and data management
61 Ability to work independently on multiple projects with ability to prioritize tasks
61 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
61 Responsible for driving study results to be published in peer-reviewed journals
61 Set and manage deliverables for contracts to align with research strategy
61 Develop and maintain overall dashboard of clinical studies, including major milestones, objectives, and financial aspects.
61 Partner with Legal and Finance team to ensure researchers are reimbursed in compliance with their contracts.
61 Presents study results/updates to various internal stakeholders cross functionally, as needed.
61 Select and hire high quality staff; develop on-boarding processes; ensure staff has materials, systems, and training to fill job responsibilities.
61 Lead clinical resourcing through continual evaluation of existing and future resource alternatives; initiate proactive planning and collaboration with leadership and operational peers.
61 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
61 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.
61 Lead or participate in departmental process improvement initiatives
61 Manage staff in accordance with organization’s policies and applicable regulations
61 Proactive, energetic, self-assured professional with high personal integrity and ability to develop good interpersonal relationships with stakeholders
61 Analytical, strategic thinker with leadership ability and style that demonstrates professionalism
61 Good teamwork and coaching skills
61 May lead the development of new systems and procedures
61 Plans, conducts, and supervises assignments
61 Reviews progress and evaluate results
61 Support continuous improvement activities
61 Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these target
61 Recruit, select, and on-board top talent
61 Develop talent within team to increase performance
61 Actively address performance issues on team
61 Maintain a high level of team engagement
61 Ability to lead a team to deliver results on multiple, simultaneous, complex projects.
Education & Experience:
61 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.
61 Preferred experience in Device or Pharmaceutical industry.
61 Preferred clinical research or project management certification (e.g., CCRP, ACRP, PMP)
61 Well organized and detail-oriented, strong written and verbal communication skills
61 2-4 years project management experience in clinical studies
61 2-4 years monitoring experience in clinical studies
Other Requirements:
61 Good verbal/written English skills
61 Resilience and accountability to deliver project excellence with passion
61 Experience in managing pre-market studies is a plus.
61 Clinical study experience in an MNC or international CRO company is a plus