Senior Clinical Study Manager (Hybrid) - New Jersey, Mahwah 325 Corporate Dr

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

As Senior Clinical Study Manager, you will be responsible for the day-to-day management of one or more clinical studies to include Investigational Device Exemption (IDE), post-approval, post-market surveillance, feasibility and/or marketing studies, and/or investigator initiated studies. You will ensure assigned studies are being conducted in accordance with GCPs, FDA regulations and department Standard Operational Procedures.  You will also provide guidance and training to and review work of CSAs, CRAs and CSMs.

• 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 process, 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.

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

• Work with clinicians, on-site research assistants, and Stryker teams to generate protocols that provide necessary information for publications, presentations or technical monographs.

• 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.

• 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.

• Lead or participate in departmental process improvement initiatives.

What you need

• Bachelor’s degree in science or health care field required

• Advanced degree (MSc, PhD) in biomedical engineering, sciences, health outcomes research, or related field preferred.

• 7+ years of related clinical research experience, preferably in clinical study management

• 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.

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