Director/Sr Director - Clinical Project Management

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Frontage Laboratories

Secaucus, NJ

Posted: over a month ago
Full-Time

Job Description

Director/ Sr Director of Clinical Project Management

Company: Frontage Labs., Inc.

Division/Department: Frontage Clinical Services

Reports to: President

Full-time

Location: Secaucus NJ, will consider remote (US)

Job/Req.

Job Summary

Responsible for oversight of Frontage Clinical Services Project Managers, and for Project Management duties, to provide project oversight to maximize the effective use of project resources, to facilitate communication among team members, including client personnel, senior management, functional group leaders, and clinical site personnel; to proactively address issues, devise templates, plans and generate or update SOPs, and to oversee the implementation and data analysis of clinical studies to facilitate their conduct in accordance with FDA GCP guidelines and applicable regulations.

Responsible for supporting Frontage Clinical Services capabilities to support multi-site studies, including Phase 1 Oncology studies and other patient studies.

Essential Duties & Responsibilities

% of Time

Duties & Responsibilities

25%

Mentor, lead and provide direction to and guidance to Frontage Clinical Services Project Managers. Train new Project Managers, complete annual reviews and developmental goals for Project Managers

25%

Support expansion of Frontage Clinical Services capabilities to support patient studies.

30%

Project Management duties:

Develop a project plan for each study, manage and coordinate the activities of projects, including development of timelines and deliverables, and communicate to all contributing team members.
Organize and host regularly scheduled and ad hoc meetings with the sponsor and/or third-party vendors to monitor study progress, issue agenda and meeting minutes.
Manage vendor contracts.
Maintain communications with sponsor, clinical site personnel, third-party vendors and Frontage team members.
Regularly communicate with senior management on matters concerning resource allocation, project milestones, regulatory issues, risks, issues and other relevant issues.
Establish and maintain components of the Trial Master File and deliver to the sponsor at the completion of each study.
Develop Project Management-related documents, such as SOPs, Plans, Templates.
Review and provide comments on clinical study-related documents including Protocol, Informed Consent Form, and Clinical Study Report. May be asked to author documents.

10%

May develop and/or manage clinical study contracts, budgets, change orders and proposals.

10%

Coordinate problem solving of diverse scope where analysis of data requires evaluation of identifiable factors. Keep senior management apprised of risks and issues.

100%

Minimum Job Requirements & Qualifications

Educational/Training Requirement:

Requires a Bachelor’s degree or higher, preferably, in a scientific discipline or equivalent.

Experience:

A minimum of 5 years of project management experience in clinical research in the pharmaceutical and/or contract research organization industry, and at least two years of project management/project leader experience with multi-site patient studies. Equivalent experience may be considered.

Licenses/Certifications (if applicable):

PMP Certification a plus, but not required.

Knowledge, Skills, and Abilities (KSAs):

Strong working knowledge of ICH guidelines and GCPs required
Excellent verbal and written communication and time management skills are essential.
Proficient in use of Microsoft Word, Excel and Project
Ability to interact with clients, all levels of management, vendors, and study site personnel.

Supervisory Responsibility

List the job titles that directly report to this job (formal supervision).

Project Managers
Project Manager Assistants
QC Associate
Medical Writers

Travel Requirements

Americans with Disabilities Act (ADA)
PHYSICAL DEMANDS and work environment CHECKLIST

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. These may include lifting, pushing, climbing, degree of eyestrain, sitting for extended periods of time, prolonged standing, etc. Frequency refers to the amount of time one is engaged in the activity; please estimate time by checking the appropriate boxes.

Physical Demands

Physical Demand

None

Rarely

Occasionally

Frequently

Constantly

Weight

Standing

Walking

Sitting

Lifting