Senior Clinical Project Manager

Duality Biologics; United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Duality Biologics seeks a senior Clinical Operations Leader to head the project management and CRA teams, coordinating in-house staff and CROs to ensure trial quality, timelines and budget adherence. The role involves risk assessment, budget oversight, and cross-functional collaboration across clinical operations and supply chain.

The candidate should hold a biology/healthcare degree with 8+ years in Clinical Operations, including 5+ years in project management and 2+ years as CRA/SCRA, and

Qualifications

• Bachelor's degree in biological sciences or healthcare-related field required.
• Minimum 8 years of experience in Clinical Operations or related field with at least 5 years in project management.
• Minimum 2 years of experience as CRA/SCRA.
• Clinical research background with medical/scientific knowledge preferred.
• Excellent written and spoken English.
• MS Office suite and MS Project proficiency.
• Bilingual is a must.
• Strong communication and presentation skills.

Responsibilities

• Lead the project management and/or CRAs team, including in-house staff and CROs, to ensure study quality, timeliness and budget adherence.
• Regularly meet with team members to track task progress and milestones.
• Monitor trial status and adjust plans to meet deliverables.
• Identify and mitigate trial-level risks and develop integrated risk plans.
• Resolve complex study problems proactively.
• Develop and monitor study budgets and assumptions.
• Manage CRO qualification, selection, and oversight in compliance with SOPs and local regulations.
• Oversee CRO and site budgets and communicate deviations with proposed solutions.
• Support protocol development and cross-functional collaboration.
• Coordinate with supply chain for clinical supplies management.
• Ensure compliance with SOPs, GCP, ICH guidelines; oversee audits and regulatory inspections.
• Develop recruitment strategies and monitor enrollment vs targets.
• Plan country-level operational plans for studies within a development program.

Skills

Project management

Clinical operations

Budget management

Risk management

Vendor management

Communication skills

Education

Bachelor's degree in biological sciences

Master's degree preferred

Tools

MS Office Suite

MS Project

Job description

This role is responsible for leading the team of project management and (or) CRAs if applicable. Including but not limited to the project timeline control, oversees the key deliverables, and project milestones for ongoing clinical trials.

When needed, this role will also be responsible for the development and management of a portfolio of projects and/or programs, with respect to the delivery of quality project management services.

• Lead the project management and (or) CRAs team including in-house team members and Contract Research Organizations (CROs), vendors and other suppliers to ensure study quality, timeliness and adherence to budget.
• Meet with team members on a regular basis regarding project tasks to ensure project achievements.
• Monitor the status and make changes as needed to meet the deliverables of the trial.
• Assess, identify and monitor trial-level risks. Incorporate scientific knowledge, trial process, and expertise to create one integrated trial-level risk mitigation and contingency plan.
• Identify and facilitate resolution of complex study problems and issues proactively.
• Create and monitor the overall budget and assumptions using financial tracking tools.
• Manage CRO qualification process, selection, and oversight to ensure that all clinical trials’ execution with SOP and local laws and regulations.
• Manage CRO and site budgets, communicate deviations from budget projections, and propose solutions for budget deviations.
• Support with cross-functional team to facilitate the trial protocol development and maintenance process.
• Collaborate with supply Chain team to develop and complete of the request and management for Clinical Supplies.
• Provide input to process development and improvement.
• Work with the internal quality control and site to ensure high quality of trial.
• Conduct QCV or CO-monitoring visit if needed;
• Plan and lead activities associated with audits and regulatory inspections.
• Develop and actively manage clinical trial recruitment strategies with evaluation of actual enrollment against assigned targets and working with investigational sites to meet, and whenever feasible, exceed enrollment targets.
• Develop and coordinate country level operational plans for a clinical study or multiple clinical studies within a development program (i.e. study timeline projection, drug and budget forecast, safety plan, monitoring plan, study management plan, issue escalation and resolution plan).
• Ensure that work is conducted in compliance with professional standards and meet quality and timeline metrics. Ensures compliance with SOP's, GCP and ICH guidelines.

Qualifications:

• Bachelor Degree, biological science or healthcare-related field, Master Degree or higher is preferred.
• Minimum 8 years of experience in Clinical Operations or other related fields with minimum 5 years of project management experience
• Minimum of 2 years of experience as CRA/SCRA
• Clinical research background, with medical and scientific knowledge preferred
• Excellent knowledge of spoken and written English.
• Working knowledge of MS Office suite and MS Project or equivalent
• Strong communication and presentation skills
• In-depth knowledge of applicable clinical research trails regulatory requirement (i.e：GCP and ICH guideline)
• Bilingual is a must
• Solid problem solving and time management skills