Job Title: Senior Project Manager
Location: Hybrid in Philadelphia, PA
Hours/Schedule: Full Time, 40 hours a week
Type: Direct Hire
Overview Joule is currently looking for a Senior Project Manager to work with one of our clients in the Philadelphia, PA area. In this role you will be working under the direction of the Senior Director, Clinical Research, and will be responsible for the overall management of all projects including liaising between the funder and the project team for oncology clinical trials managed by the organization. The Senior Project Manager coordinates the efforts of all project teams to ensure that all aspects of all projects as defined in the contract are occurring on schedule and within budget.
Other Responsibilities- Assists the Sr. Director in all aspects of clinical trial management.
- Reviews contract, protocol, budget, and Case Report Forms (CRF's) in the development of the scope of the project.
- Coordinates and oversees the development of project teams including members of Medical, Data Management, Regulatory, Monitoring, and Clinical Supplies departments as needed.
- Oversees the development and implementation of the project plan.
- Assures that all project tasks are performed per SOPs and integrated project-specific SOPs per the clinical trial sponsor, and includes the development, review, and implementation of Project Specific Plans (PSPs).
- Provides overall direction for study issue resolution.
- Communicates with management and fiscal personnel to ensure ongoing budget compliance through project completion.
- Ensures that the study is in compliance with federal requirements, that data has been accurately reported and that all queries have been timely resolved.
- Ensures that the project team communicates with funders, monitors, CRAs and sites to confirm that all protocol amendments, revisions to the Investigator’s Brochure and /or significant new adverse effects or risks with respect to study drugs are distributed to all participating sites.
- Provides mentoring and training to junior staff including PMs, Associate PMs and CRAs.
- Maintains a positive interaction with funders’ representatives.
- Attends relevant meetings for sponsor-related activities, cooperative groups, and the organization’s staff meetings.
- Provides appropriate status reports to clinical trial sponsor, Sr. Director, Clinical Team Manager, and Vice President and communicate any problems at the site, especially those involving patient safety issues.
- Provides information to the Director and Vice President for proposals for new contract bids, including projected resource allocation for project management time, number of monitors, and monitoring time.
Requirements- Bachelor’s Degree from an accredited college or university is required. An appropriate Master’s Degree and SOCRA certification is preferred.
- A minimum of ten (10) years strong health care related background with prior oncology clinical trial management and/or data management services experience is required.
- Experience in pharmaceutical industry, contract research organization, site network and multisite trial management experience is required.
- Computer literate in Microsoft Office and other required and related systems. Mastery of Excel is required.
Ref: #568-Clinical
Skills:
Biotech and Pharmaceutical, Budget Management, Budget Reporting, Budgeting, Case Report Form (CRF), Clinical Monitoring, Clinical Research, Clinical Trial, Clinical Trial Management, Computer Skills, Contract Research Organization (CRO), Contract Review, Data Management, Drug Dispensing, Federal Compliance Regulations, Healthcare, Maintain Compliance, Medical Products, Mentoring, Microsoft Office, Monitor Regulations, Oncology, Organizational Development/Management, Patient Safety, Problem Solving Skills, Project Development, Project Estimates, Project Planning, Project/Program Management, Resource Management, Side Effects, Society of Clinical Research Associates (SoCRA), Standard Operating Procedures (SOP), Status Reports, Team Lead/Manager, Time Management, Time Tracking, Training/Teaching
About the Company:
Joulé
Our Story
Impacting lives. It's in our DNA.
At Joulé, we believe our world is filled with possibilities – where character, integrity and commitment drive our purpose. For over 30 years, Joulé has been a trusted partner to industry leading clinical, scientific, and healthcare organizations by providing innovative workforce solutions and delivering top talent. Operating at the forefront of the life sciences arena, Joulé’s relentless approach enables our clients to rapidly and effectively execute critical initiatives and major projects. Joulé is a System One division.
Joulé consists of multiple business lines working together for client success: scientific, clinical, and healthcare recruiting plus equipment services.
Since our existence, we’ve excelled in these specialized markets, and in recent years we have further narrowed the Joulé brand to exclusively represent these arenas. Joulé's services are backed by the considerable reach and resources of our parent company, System One.
The Business of Science
Way back before STEM was a trend, Joulé established its roots in scientific and technical disciplines. We began life as an engineering services firm, but our business has evolved considerably to where it stands today:
- A leader in specialized workforce solutions and integrated services
- One of the top ten largest clinical and scientific staffing firms in the U.S.
- An ISO-certified provider of laboratory and facility support
- An advocate for scientific, clinical, and healthcare clients and candidates alike
National Reach with Local Expertise
Working at the intersection of business and science, we make it easier to recruit and deploy talent for ongoing work and on-demand projects in a host of disciplines. We’re still writing our story, but our future is built on a foundation of quality delivery and personalized service.
Company Size:
100 to 499 employees
Industry:
Staffing/Employment Agencies
Founded:
0
Website:
https://www.jouleinc.com/
