Project Manager at CenExel

, , United States -

Full Time

Start Date

Immediate

Expiry Date

11 Jul, 26

Salary

0.0

Posted On

12 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical research, Project management, Regulatory compliance, FDA regulations, ICH GCP, Cross-functional leadership, Study start-up, Site initiation, Budget management, Vendor management, SharePoint, Excel, MedDRA coding, Pharmacovigilance, Trial Master Files, Audit readiness

Industry

Research Services

Description

About Us: CenExel is a leading nationwide clinical research site and patient network serving the life sciences industry. Leading in CNS and early phase studies, our 18 science-led Centers of Excellence deliver the right patients, at the right time, in the right place. Recently acquired by BayPine Capital Partners, our research sites provide unparalleled medical and scientific support in the design and execution of clinical trials. Our world-class PIs, advanced patient engagement strategies, premium data analytics, and integrated operations optimize every step of the clinical trial process. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. Job Summary: The Sponsor Research Division Project Manager oversees the planning, execution, and close-out of clinical research studies for single and multi-site studies. This role ensures operational excellence, regulatory compliance, and timely delivery of study milestones. The ideal candidate is detail-oriented, proactive, and thrives in a fast-paced, cross-functional environment. Essential Responsibilities and Duties: * Leads cross-functional teams through all phases of clinical trial execution, including study start-up, conduct, and close-out phases; Develops and manages project timelines and deliverables; Monitors progress against milestones and proactively address risks or delays; Tracks enrollment metrics, protocol deviations, and site performance; Optimizes resource allocation and capacity planning. * Serves as primary contact for sponsors and external vendors; Coordinates with sponsors, CROs, and internal teams to ensure alignment; Facilitates communication across teams by conducting regularly scheduled team meetings; Liaises with CenExel Site Project Managers and with the CenExel Site Optimization Group to ensure on-time delivery of clinical deliverables. * Identifies, qualifies and manages vendors according to project needs and CenExel Standard Operating Procedures; Obtains bids from Contract Research Organizations as needed to support full-service solutions for sponsor research activities. * Manages project according to Operational Study Plans (Project Management Plan, Monitoring Plan, Clinical Site Blinding Plan, etc.); Plans / Facilitates / Conducts Kick-Off Meetings, Site Initiation Visits (SIVs), and Study Team Meetings; Oversees Clinical Research Associate activities and scheduling, including review and approval of monitoring reports. * Coordinates regulatory document collection, IRB submissions, and site activation activities; Collaborates with Regulatory Affairs to manage IRB submissions and approvals; Maintains Trial Master Files (TMF); Reviews and approves study-related documents (e.g., ICFs, CRFs, logs); Supports audit readiness and CAPA implementation. * Coordinates shipment and tracking of study materials and investigational product (IP) documentation. * Conducts training on protocol amendments and regulatory updates; Provides training and mentorship to site coordinators and support staff. * Collaborates with CenExel Business Development and Finance teams to develop accurate cost estimates for Sponsor Research Division activities during the bidding process; Liaises with the CenExel Business Development and Finance teams to create unified proposal packages. * Monitors and reports financial milestone tracking to CenExel Finance and Accounts Payable; Approves project-related expenses and assists with reconciliation of discrepancies; Identifies potential cost overruns and implements corrective actions to maintain budget integrity; Tracks protocol amendments and scope changes that may impact financial projections; Supports change order development and sponsor negotiations when financial adjustments are required; Ensures transparency and responsiveness in financial communications to maintain sponsor trust and satisfaction. * Supports audit readiness and maintains complete, compliant documentation. * Liaises with Regulatory, QA, Site Optimization and Data Management teams. * Tracks enrollment metrics, protocol deviations, and site performance. * Liaises with CenExel Site Project Managers and with the CenExel Site Optimization Group to ensure on-time delivery of clinical deliverables. * Contributes to SOP development and process optimization initiatives; Implements SOPs, checklists, and templates to standardize workflows; Drives continuous improvement initiatives across clinical operations. * Supports and ensures strictest adherence to best practices, FDA Code of Federal Regulations, ICH (International Conference on Harmonization), GCP (Good Clinical Practices), CenExel standard operating procedures, site working Practices, protocol, and company guidelines and policies. * Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: * Bachelor’s degree in life sciences or related field. * 4+ years of clinical research experience (Project Management experience preferred). * ACRP certification a plus. * Strong knowledge of FDA regulations and ICH GCP. * Proficiency in SharePoint, Excel, and project management tools. * Experience with multi-site trials and sponsor/CRO collaboration, preferred. * Familiarity with MedDRA coding and pharmacovigilance workflows. * Excellent communication, organizational, and leadership skills. Working Conditions 1. Essential physical requirements include sitting, typing, standing, and walking. 2. Lightly active position, occasional lifting of up to 20 pounds. 3. Reporting to work, as scheduled, is essential. 4. Remote or hybrid work arrangement. 5. 40-60% travel may be required (e.g. Site Initiation Visits or training or observing site CRAs). CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.

Responsibilities

The Project Manager oversees the planning, execution, and close-out of clinical research studies while ensuring operational excellence and regulatory compliance. They lead cross-functional teams, manage project timelines, and serve as the primary contact for sponsors and external vendors.