Responsible and accountable for the management of all operational aspects of assigned clinical studies as directed by the Sr. Manager, Clinical Operations. Works closely with various cross-functional partners both internally and externally, including medical and scientific personnel. Leads the execution of the study plans and cross-functional project team to ensure that all study operational activities are conducted efficiently, meet enrollment goals and are in compliance with all applicable regulations and Corporate SOP’s. Approximately 25% of work time will be spent traveling (international and domestic). Essential Job Functions:
Directs the planning and execution of all operational activities of the assigned clinical studies including but not limited to, project operational plans, clinical study protocols, informed consent and case report forms, budgets, status reporting, interim analyses, and final clinical study reports.
Assists with protocol development, CRF design, and any other clinical document writing as needed.
Manages and tracks overall study budget, tracks and administers payments, provides financial reports as requested.
Interacts with KOLs, medical advisors, and site investigators.
Facilitates team coordination and work flow for multiple projects.
Manages multiple project timelines and resources as assigned.
Forecasts trial resource needs (headcount and external costs).
Maintains responsibility for delivering high quality clinical data according to timelines and within budget for assigned trials. Escalates risks and issues to senior management as appropriate.
Communicates up-to-date information regarding project status to all relevant interested parties, including Senior Management.
Obtains and negotiates contracts with vendors for study operations.
Oversees and manages study vendors and external Contract Research Organizations to ensure successful study execution and adherence to scope of work.
Leads project team meetings.
Interacts with team members to ensure all study operational documents, including the Trial Master File, are in order prior to starting the study and monitor compliance to these plans during the study.
Leads site identification and final site selection activities and ongoing site oversight.
Responsible for ensuring compliance with company standards, policies and procedures, Good Clinical Practice (GCP), and local, regional, and federal regulations.
Performs site visits as needed.
Oversees management of device shipments and inventory.
Ensures proper collection and reporting of adverse events, including liaison with both internal and external Medical reviewers and participation in safety review meetings.
Coordinates study and site audits to ensure ongoing monitoring of compliance within the study(s).
Works with cross-functional team members to prepare data for regulatory submissions.
Schedules and organizes Investigator Meetings, receptions, safety data review meetings, and other study-related meetings
Assists the Clinical Affairs management in developing Clinical Affairs standard operating procedures and processes.
Performs special projects and other duties as assigned.
Bachelor’s to advanced degree in biologic science or other related field.
Minimum of four (4) years clinical research experience in the medical device (preferred) or pharmaceutical industry.
Minimum of two (2) years leading high performing clinical project teams.
Experience in cardiovascular or pulmonary diseases preferred.
Strong project management skills, including the ability to handle multiple assignments.
Demonstrated efficiency in partnering with CROs and vendors.
Proficient working knowledge of GCP, ICH, and regulations related to clinical trials.
Works proactively and efficiently in a fast-paced, high change environment.
Effective communication and interpersonal skills.
Attention to detail.
Excellent organizational skills.
Adept at developing and implementing metrics and clinical study patient recruitment strategies and exhibit strong presentation skills.
Ability to interact positively with all levels of staff and liaise successfully with all levels of management in addition to being a strong team player.
Experience managing project budgets.
C. R. Bard, Inc.
Website : http://www.crbard.com