Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.
Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra’s Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."
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
ESSENTIAL DUTIES AND RESPONSIBILITIES
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Budget and Contract Coordination:
- 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
Departmental Management and Staff Development:
- 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
Coordination, Communication and Administration:
- 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.