Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Summarized Purpose:
Provides experienced contracted project coordination and safety support on global and domestic programs with an emphasis on Data and Safety Monitoring Boards (DSMB) and Endpoint Adjudication Committees (CEC). Performs DSMB/CEC set-up, member contract execution and tracking. Administers
member payment set up, member management and oversight, polls committee members and client contacts for meeting dates and times. Arranges meeting facilities as needed for all contracted meetings and attends and completes meeting minutes for DSMB/CEC meetings as contracted. Provides
oversight for all DSMB/CEC filing, assists the Safety Committee Specialist with dossier building and distribution and has a working knowledge of the Event Adjudication System. Obtains and tracks adjudication specific documents for inclusion into dossier. In collaboration with Safety Committee Specialists, liaises and establishes effective relationships with internal functional team members to
implement projects, prepare contractual documents, coordinate and facilitate meetings and accurately manage all contracted services for DSMB/CEC.
Essential Functions:
- Represents the DSMB/EAC Coordination Team at global and domestic committee meetings (both via teleconference and face-to-face) alongside the client, board members, third party vendors and the company's project team, coordinating all logistical aspects and assisting with facilitation.
- Interfaces with various internal and external parties to implement contracted DSMB / Adjudication services for projects, prepare Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements based on contractual considerations, reviewing all contractual documents for accuracy and coordinating internal and external approvals.
- Compiles adjudication dossiers and creates/submits follow-up to investigative sites.
- Coordinates/facilitates project meetings, drafts meeting minutes, posts blinded and unblinded minutes/materials to client portals and distributes to internal and external project teams.
- Manages project specific training and the set-up, maintenance and archival of program files; ensuring PV remains audit ready.
- Identifies and redacts subject identifiers per local requirements, retrains sites and escalates reoccurrences to the company's Data Privacy.
- Performs data entry into internal/external databases, tracking systems; performs system reconciliations to identify issues which may negatively impact project timelines.
- Oversees expenses/invoicing including committee, travel or translation expenses ensuring proper escalation as needed for timely member payment.
- Supports any specific activities performed by the specialty committee team, which can be assisted by administrative support.
- Develops training materials and supports management with project budgetary management.
- Acts as Subject Matter Expert for one or more of PVs processes and/or systems.
- Authors non-critical quality events: identifying process improvements, resolving issues for both departmental and project specific tasks and identifies needed modifications to PV tools and templates.
- Mentors junior staff as needed.
Qualifications:
Education and Experience:
- High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
- Technical positions may require a certificate
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 4 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Ability to assist in the management of a large project and to provide work diretion and training to other support staff working on the project
- Strong critical thinking skills and ability to use problem-solving techniques applicable to constantly changing environments
- Strong problem-solving skills
- Ability to work independently with minimal supervision, demonstrating initiative
- Ability to build strong relationships
- Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency
- Ability to act as a liaison and communicate respectfully and diplomatically with all clients, management, project team members and other internal staff
- Self-motivated, positive attitude with effective oral and written communication and interpersonal skills
- Excellent computer skills to include MS Office (Word, Excel, PowerPoint, Access)
- Ability to identify and set priorities and effectively perform a variety of tasks simultaneously with strict deadlines
- Strong attention to detail and accuracy with orientation toward careful and meticulous work
- Ability to maintain a positive and professional demeanor in challenging circumstances
- Flexibility to reprioritize workload to meet changing project timelines
- Demonstrated ability to attain and maintain a strong knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and the company's/Client SOPs for all non-clinical/clinical aspects of project implementation, execution and closeout
Thermo Fisher values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Ability to use and learn standard office equipment and technology with proficiency.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- May require travel. (Recruiter will provide more details.)