• Integra LifeSciences Corporation
  • Bergenfield , NJ
  • Non-Executive Management
  • Full-Time
  • 30 W Clinton Ave

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The Clinical Research Manager is responsible for all aspects of clinical study operations for assigned Integra LifeSciences clinical projects according to the strategy defined by the leadership of Integra s Global Clinical Affairs team and in accordance with Good Clinical Practice (GCP), ICH Guidelines, and applicable federal or national regulations. They are responsible for the operational and financial management of clinical study planning and execution for assigned projects and leadership of the Study Core Team. Close collaboration with stakeholders within Clinical Affairs and across various business functions is required. Ensures project budget is developed and managed in line with organizational expectations, including the development of appropriate site budgets. Responsible for the financial management of the clinical trial program including budget planning, resource allocation, preparation of quarterly reports and investigator payments as applicable. Leads clinical operations including: Design, initiation, coordination of clinical studies to support regulatory submissions, as well as post-market clinical trials. In case of CRO managed studies: leads CRO evaluation and selection process, and provides ongoing CRO oversight. Accountable for all project timelines and deliverables. Accountable for all aspects of vendor management for assigned studies and responsible for driving vendors to complete their activities in accordance with contracted terms. Coordinates the preparation of state-of-the-art study documentation by leveraging cross-functional resources and their expertise. Documentation may include, but is not limited to, protocol, statistical data analysis plan, monitoring plan, informed consent form, case report form, investigator agreement and financial agreement, as required. Leads Study Core Team meetings to ensure appropriate decision making and transparency with stakeholders within Clinical Affairs and the business. Evaluates and communicates the probability and impact of risks, develops quality and risk management plans, and ensures integration into the overall management of the project to ensure delivery consistent with the project plan Oversees the development of the eCRF or CRF as appropriate. Oversees the feasibility and site selection process through collaboration across Clinical Affairs and with key stakeholders. Remains accountable for the final determination of the study site list from the site selection process. Leads preparation and provides input into materials for Investigator Meetings, Initiation Visits, Training Meetings, and similar study related activities. Coordinates and holds responsibility for ensuring that all data pertaining to study status is compiled and reported monthly as appropriate. Ensures compliance with all applicable regulatory standards related to clinical studies and interactions with physicians. Continues to increase knowledge of medical device development process, ICH-GCP and applicable FDA and local/international regulatory requirements. Leads the planning and management of study site activities and provides ongoing updates of site status to management. Supports data collection, assessment and reporting activities. Works closely with Data Management for the design and execution of appropriate data management practices, including the use of electronic data capture (EDC). Ensures timely entry of clinical study information into the clinical trial management systems (CTMS), eTMF, EDC, www.clinicaltrials.gov and other relevant systems to create transparency into study progress and activity. Works collaboratively with Medical Writers for the writing and editing of manuscripts, protocols, IDE submissions, CSRs, outlines, tables, and figures for clinical publications. Supports regulatory affairs personnel with clinical sections of regulatory submissions and study related communication with regulatory agencies. Collects, reviews and tracks regulatory documents when required. Anticipates/identifies potential problems and implements corrective actions on clinical trials. Responsible for ensuring that staff are consistently driving and partnering with the project teams to ensure transparency and partnership structure that assures the appropriate updates are provided, that performance is to their expectations, and that there is clear understanding of expectations as a project team member from the function to ensure the success of a matrix management structure. Exhibits active mentorship of study team to build talent across the department. Exhibits active leadership in project teams. Actively follows and manages the application and communication of all Integra policies, procedures, and Values and helps to instill in all staff across Clinical Operations. Assists in updating corporate Standard Operating Procedures (SOPs) to support adherence to company policies and procedures concerning Clinical Affairs, in coordination with Global Clinical Affairs team members Supports and communicates functional, departmental or organizational initiatives Supports the identification of training gaps within Clinical Affairs functions, supports the development of training materials to meet that gap, and provides training as required to improve core competency and skill set of the department. Supports the maintenance of guidelines, training programs, policies and procedures Ensures compliance with the application and communication of all Integra policies, procedures and values within the matrixed team Ensures that all team members understand and work towards corporate and department goals. Ensures that all team members understand the priorities of the business, that they are focused on those priorities and that their level of accountability is understood and accepted within a matrix environment. Leads or participates in quality and continuous improvement efforts to increase overall effectiveness of the Clinical Operations team. Interfaces with Global Clinical Affairs, Legal, R&D, Marketing and Sales to ensure that clinical activities are in line with overall strategic goals. Represents the company at conferences, regulatory meetings, and relevant trade associations. Accurately completes administrative activities such as time reporting and expense reporting in a timely and accurate manner. Ability to travel 20% to 50% of time. Works with department staff to support and achieve department objectives. Works with Global Clinical Affairs members at other location to coordinate and streamline clinical operations worldwide. Interfaces with other departments (R&D, Marketing, Sales, Legal, Regulatory, Quality) to represent the clinical department and ensure effective inter-department communication and collaboration. Works closely to establish collaborative relationship with KOLs and/or clinical trial investigators. Bachelor s Degree in LifeSciences, Pharmaceutical or related Sciences required. Advanced degree (PhD, PharmD, MPH, MBA, ...) is a plus. A minimum of five to seven years of progressively responsible experience in clinical research within a medical device, pharmaceutical, biotechnology, CRO, and/or healthcare setting required. A minimum of one year of on-site monitoring experience or related equivalent experience required. International study management experience is preferred. Demonstrated analytical, negotiation, meeting management, cross-functional team and leadership skills at a management level are required Demonstrated ability to effectively interact with and collaborate at all levels in the organization, including effective interfaces at the senior management level Strong interpersonal, verbal and written communication skills. Ability to form strong and constructive internal as well as external professional relationships Detail oriented, excellent organizational and management skills Position requires composition ability, data analysis skills, scientific writing and presentation skills Must have the demonstrated core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan Experience in applied science, leadership skills and ability to merge science with business goals preferred. Experience in design and development of scientific research protocols, clinical investigational plans, and regulatory strategies preferred Thorough knowledge of FDA guidelines and regulations, ICH guidelines and Good Clinical Practices (GCP) governing the conduct of clinical trials required Experience in collaborations with relevant trade organizations, as well as hospitals and physicians preferred Must be computer literate with working knowledge of Microsoft Office Project management certification or relevant experience is a plus

* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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