Clinical Trial Operations Project Manager

Insight Global; Spring House (PA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Benefits package starting day one

401(k) after 90 days

Paid time off

Job summary

Insight Global is seeking a seasoned project management professional for its Oncology Biomarker & Diagnostic Operations team in the Greater Philadelphia area. The role focuses on implementing clinical biomarker and diagnostic strategies and coordinating sample collection, testing and data delivery across early to late-phase oncology programs.

You will bridge science and operations through cross-functional partnerships, manage timelines and budgets, and ensure high-quality data and site

Qualifications

• Bachelor's degree in a scientific discipline.
• 5+ years of clinical development, biomarker or diagnostics R&D experience.
• Strong knowledge of clinical drug development planning, ICH GCP, GLP.
• Excellent written and verbal communication; ability to work in global cross-functional teams.
• Ability to work fully onsite in Spring House, PA for multi-year assignment.
• USC, Permanent Resident, GC or H4 EAD holder able to work on Insight Global's W2 without sponsorship.

Responsibilities

• Drive the implementation and execution of the clinical biomarker and diagnostic strategy for early and late-stage oncology programs.
• Create and manage biomarker and diagnostic plans, timelines, budgets, risk assessments, and quality metrics.
• Coordinate contracts and statements of work with procurement and scientific leads to meet deliverables.
• Contribute to central lab setup and management throughout the study.
• Manage relationships with specialty testing vendors to ensure data delivery meets timelines.
• Work with data management to establish data collection and transfer processes with testing vendors and labs.
• Prepare clinical documents such as protocols, studies reports, lab manuals, informed consent forms, sample management plans and site training materials.
• Identify innovative biosample collection and processing techniques and ensure site implementation.
• Develop presentations and present sample tracking/testing metrics at team meetings.
• Collaborate with internal and external partners to ensure on-time, quality deliverables.
• Participate in cross-functional study team meetings across clinical, translational research and diagnostics.

Skills

Communication

Cross-functional collaboration

Global teamwork

On-site work

Education

Bachelor's degree in a scientific discipline

Job description

One of Insight Global's clients is seeking a skilled project management professional to join their Oncology Biomarker & Diagnostic Operations team based in the Greater Philadelphia area. As a key contributor to the clinical biomarker and diagnostic strategy, they will be accountable for the implementation and execution of clinical sample collection, testing and data delivery activities for both early and later-phase clinical programs in oncology. To be successful, this candidate should have experience bridging both science and operations through cross-functional partnerships, strategic project planning and facilitating key biomarker and diagnostic execution discussions.

Key Responsibilities:

• Drives the implementation and execution of the clinical biomarker and diagnostic strategy for clinical programs in early and late-stage oncology.
• Creates and manages biomarker and diagnostic plan, timelines, budget, risk assessments and quality metrics during study startup, conduct and closeout.
• Work effectively with procurement and scientific leads to execute contracts and statements of work to meet program deliverables.
• Contributes to central lab setup and management throughout the course of a study.
• Manages relationships with specialty testing vendors to ensure biomarker/diagnostic samples are processed, tested and data is reported to meet development timelines and specifications.
• Works closely with data management to establish data collection and transfer processes with testing vendors and local labs.
• Contributes to the preparation of clinical documents such as clinical protocol, clinical study reports, lab manuals, informed consent forms, sample management plan, early development plans and site training materials.
• Works with scientific stakeholders to identify innovative biosample collection and processing techniques and ensures methods are implemented appropriately across clinical sites to the highest of standards.
• Develops presentations and presents sample tracking/testing metrics at regular team meetings.
• Manages relationships with internal and external partners to ensure on-time and quality deliverables.
• Participates in cross-functions study team meetings across clinical, translational research and diagnostics.

Required Qualifications

• A minimum of a Bachelor's Degree in a scientific discipline.
• 5+ years of work experience in clinical development, biomarker or diagnostics development and/or Pharmaceutical/biotech R&D.
• Strong knowledge and understanding of clinical drug development strategic planning of clinical research, ICF, ICH GCP, GLP.
• Excellent written and verbal communication skills. Ability to effectively and collaboratively work on global cross-functional teams.
• Ability to work fully onsite in Spring House, PA area over the course of a multi-year assignment.
• USC, Permanent Resident, GC or H4 EAD holder able to work directly on Insight Global's W2 without needing sponsorship now or at any time in the future.

Preferred Qualifications

• Advanced degree such as a MS or PhD or a project management certification.
• Knowledge of oncology drug development and/or biomarker/diagnostic development.

Compensation

$120,000 to $150,000. Paid on hourly basis; guaranteed 40 hours per week. Intended to be a multi-year, W2 contract; opportunity for permanent conversion and/or extensions year over year. Exact compensation will vary based on several factors, including skills, experience, and education.

• Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance.
• Eligibility to enroll in the 401(k) retirement plan begins after 90 days of employment.
• Additionally, employees in this role will have access to paid sick leave and other paid time off benefits.

W2 ONLY. No C2C, subcontracting or employment/visa sponsorship now or at any time in the future.