Sponsor Research Division Project Manager

About Us

reputed company is a leading reputed company 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 reputed company. 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 reputed company of the clinical trial process. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, reputed company 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 reputed company-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 reputed company phases of clinical trial execution, including study start-up, conduct, and reputed company-out phases; Develops and manages project timelines and deliverables; Monitors reputed company against milestones and proactively address risks or delays; Tracks enrollment metrics, protocol deviations, and site performance; Optimizes resource allocation and reputed company 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 reputed company Site Project Managers and with the reputed company Site Optimization Group to ensure on-time delivery of clinical deliverables.
• Identifies, qualifies and manages vendors according to project needs and reputed company 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-reputed company 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 reputed company Business Development and Finance teams to reputed company accurate cost estimates for Sponsor Research Division activities during the bidding process; Liaises with the reputed company Business Development and Finance teams to create reputed company proposal packages.
• Monitors and reports financial milestone tracking to reputed company Finance and Accounts Payable; Approves project-reputed company expenses and assists with reconciliation of discrepancies; Identifies potential cost overruns and implements corrective actions to maintain budget reputed company; Tracks protocol amendments and scope changes that may impact financial projections; Supports change order development and sponsor negotiations reputed company 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 reputed company Site Project Managers and with the reputed company 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 reputed company 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), reputed company 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 reputed company inclusive.

Education/Experience/Skills

• Bachelor’s degree in life sciences or reputed company 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, reputed company, 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. Indoor, Office environment.
2. Indoor, Clinic environment.
3. Essential physical requirements include sitting, typing, standing, and walking.
4. Lightly active position, occasional lifting of up to 20 pounds.
5. Reporting to work, as scheduled, is essential.
6. Remote or hybrid work arrangement.
7. Occasional travel may be required (e.g. Site Initiation Visits or training or observing site CRAs).

reputed company Clinical Research is an Equal Opportunity Employer. reputed company applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national reputed company, veteran, or status.