Remote - Clinical Project Manager I-Ii

Brio is currently working with a clinical stage CRO company that's actively looking for Clinical Project Managers. Remote - US open all across the US

Clinical Project Manager I-II

Remote - US Locations

Direct Hire / Full-Time Status

Must have atleast 1 year of Clinical Monitoring experience

Full Service CRO experience is required

Financial PM experience: Financial Oversight, Budget Forecasting, Change of Scope, etc..

Experience collaborating with Clinical Operations, Data, Regulatory, TMF teams

Salary + Benefits Package

Brio Resource Group is a Life Sciences Executive Search Firm committed to providing rare talent on an exclusive search basis to the Biopharma, Pharma, Device and CRO industries. We work on behalf of organizations that value true talent acquisition partners and specialize in supporting emerging Biopharma companies offering life-changing therapies. Our many years of experience, subject matter expertise, comprehensive search process and genuine passion to deliver rare talent defines Brio.

We work with a range of life sciences organizations across multiple industry disciplines, with one of our strongest portfolio’s in Project Management With US offices strategically located on the east coast (DC Metro) and west coast (San Diego) we connect rare life sciences talent with emerging companies nationwide.

Summary: The Clinical Project Manager (CPM) is the lead project manager for trials conducted within the CRO services division of the company and is the main interface between us and the client. S/He will work cross-functionally as needed with Clinical Data Management (CDM), Regulatory Services, Clinical Operations (CO), Budgets and Contracts, and CRA Services to ensure that studies are conducted per protocol and client expectations, on time, within budget, and according to FDA regulations and ICH GCP. Performs duties in accordance with company’s values, policies, and procedures.

Essential Duties and Responsibilities will include the following. Other duties may be assigned at the company’s sole discretion.

• Liaises with the site(s) recruitment department(s), to ensure adequate subjects are available for screening and enrollment.
• Liaises and assists with Data Management, Regulatory Services, CRA Services, Pharmaceutical Services, medical writing, medical monitors, and other departments as applicable during study set-up, project management and oversight, and project close-out.
• Owns oversight of the project and requests a change order to budgets and contracts when the project scope changes.
• Coordinates requirements for third-party vendors, including safety and specialty laboratories, biostatistics, and/or data analytics, and liaises with budgets and contracts for proposal development. Oversees vendor performance.
• Performs protocol review, site identification, feasibility, and selection, drug supply management, and site qualification, as required.
• Creates or oversees creation of additional study training materials and ensures all training is documented.
• Supports creation of high-level study timelines for proposals.
• Coordinates with CRAs to ensure Pre-Study Visits (PSVs) are conducted and reviews reports to confirm each identified site is qualified for the study.
• Responsible for set up, conduct, and close-out of multi-center trials, as well as specialized study projects.
• Collects and reports study metrics (enrollment, query rates, issues, etc.).
• Participates in client study audits, as well as internal audits conducted by quality assurance for assigned projects.
• Performs protocol review and schedules kick-off meetings.
• Creates and/or approves study documentation, including informed consent templates, project plans, case report forms, and monitoring plans and reports, and oversees Clinical Study Report (CSR) development.
• Oversees scheduling of monitoring visits and reviews Monitoring Visit Reports (MVRs).
• Builds the electronic Trial Master File (eTMF) for the project; oversees and manages the collection and filing of essential trial documents. Periodically reviews the eTMF to ensure completeness and correctness of the contents.
• Coordinates with Principal Investigator (PI)/site staff, as applicable, during study start-up and oversight activities and to ensure appropriate subject oversight, protocol adherence, and query resolution.
• Creates slides for Site Initiation Visit (SIV) and delivers or oversees the training.
• Coordinates dose escalation meetings and participates in data reviews.
• Plans and leads teleconferences with client and/or third-party vendors relative to project performance, status updates, and issue resolution.

How to Apply:

In order to be considered for the above opportunity, simply apply via LinkedIn and include your CV.

We respond to applicants who meet our position requirements, but suggest submitting your resume for future consideration for our expanding list of new opportunities surfacing daily within our Biopharma network. We have a strict honor code at Brio respecting your confidentiality and we only share your information with your consent.

Brio Resource Group, LLC considers all applicants without regard to race, color, religion, sex, national origin, age, mental or physical disabilities, or any other similarly protected status.