Clinical Affairs Specialist 5 ( Clinical Project Manager)
Business Unit: Diagnostics
Requisition Number: 240360
Primary Location: United States-New York-Tarrytown
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 15%
REG Clinical Affairs Spec 5
Reporting to a Sr Clinical Manager, designs study plans and protocols, implements, monitors and completes clinical and non-clinical (analytical) trials for new product releases, regulatory filings, product modifications/claim extensions, and /or new markers in a timely manner and in accordance with regulatory requirements. The data from these studies may also support scientific publications.
The Clinical Project Manager works independently as a project team member and as a contact with clinical sites and investigators. As a core team member, the candidate will be the voice of clinical affairs and will be required to make decision on its behalf for clinically sound design.
The candidate will also be accountable for all financial responsibilities associated with the execution of these studies (compliance, FMV, accruals and budget forecasting).
The Clinical Project Manager works closely with Regulatory Affairs, Biostatistics and Project Management to review, prepare and implement the clinical trial strategy.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Other duties may be assigned.
• Leads the coordination of all activities related to the design and management of clinical trials of in vitro diagnostic devices. • Researches scientific evidence, appropriate CLSI documents, and current clinical use of in vitro assays in preparation for clinical protocol development.
• Designs and prepares clinical trial plans and protocols, as well as case report forms, investigator or site-specific instruction manuals and other related study documentation.
• Monitors proposed regulations and guidance documents that concern clinical trials ensuring that Clinical Affairs group remains compliant with all current and new regulations and requirements for clinical trials and protection of human subjects.
• Assists in responses during regulatory body review of product submissions.
• Maintains and ensures adherence to department standard operating procedures.
• Lead the initiation and monitoring of clinical studies to ensure protocol compliance; communicates regularly with study investigators regarding activities in all phases of the study.
• Accountable for completing and leading all activities associated with the clinical study, which may include site pre-assessment, site selection, contract negotiation, site-approvals (e.g. Internal Review Board/Ethics Committee), training, monitoring (initiation, interim, and close-out visits), and on-site audits. This includes timely identification of problems or issues that could affect the results or completion of the study, or any protocol deviations, as well as problem-solving strategies.
• Interfaces with data management and statistical staff to manage incoming clinical site data, design/maintain databases, and perform statistical analysis.
• Prepares and reviews clinical study reports and clinical sections of regulatory submissions.
• Prepares, in conjunction with the clinical investigators, scientific abstracts, posters and publications arising from the Studies.
• Develops and track study budgets and ensures that studies are completed within budget; and defines study timelines and deliverables with the core team.
• Assists in training of staff.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily, and to guide junior staff on these essential duties. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The Clinical Project Manager must also possess:
Excellent communication skills, both verbal and written
Excellent interpersonal and managerial skills
Excellent organizational skills
Excellent negotiation skills.
Demonstrate experience of developing/motivating individuals and teams.
Knowledge of regulations concerning the conduct of clinical studies for the in vitro diagnostics industry
Working knowledge of databases (e.g., Excel, Access), database management, and statistical applications
Good technical background to understand and communicate new technologies and markers and competitive products. Laboratory experience is a plus.
Ability to manage multiple high priority projects across multiple sites
An ability to demonstrate and convey our high performance culture to their co-workers.
Excellent relationships with a broad base of clinicians, laboratory professionals, and contract research organizations, who can perform field or clinical trials and who have clinical populations appropriate for specimen acquisition.
Must be capable of working with a variety of individuals outside the organization (investigators, partners) and critical functions within the company, including regulatory affairs, marketing, service and support, project management, R&D and manufacturing.
Develop and adhere to clinical study budget
Accountable for clinical study deliverables timeline.
Must be able to travel 15-25% of the time.
EDUCATION and/or EXPERIENCE
Master’s degree M.A./M.S in a health-related field with 5 years of healthcare experience or equivalent; or Bachelor’s degree B.S. in a health-related field with 10+ years of healthcare experience or equivalent. A knowledge of in vitro diagnostics clinical studies processes and regulatory requirements are a strong plus.