Associate Director, Clinical Project Management - Oncology
SystImmune
Summary
SystImmune is seeking a highly skilled and motivated Associate Director, Clinical Project Management (CPM) to oversee and coordinate global clinical trials from initiation through to completion, ensuring compliance with regulatory requirements, managing study timelines and budgets, and fostering effective communication among stakeholders.
Job description
Responsibilities
- Oversee the planning and execution of global clinical trials
- Develop and implement study protocols, timelines, and budgets
- Manage all aspects of clinical trial operations, including site selection, initiation, monitoring, and closeout
- Ensure compliance with Good Clinical Practice (GCP) and regulatory guidelines
- Coordinate with cross-functional teams, including investigators, vendors, and regulatory bodies
- Monitor trial progress and manage data collection to ensure accuracy and integrity
- Identify and mitigate project risks
- Oversee a team of regional CPMs, CRAs and CTAs
- Ensure the preparation and submission of regulatory documents are compliant with local regulatory standards and maintained per good clinical practice
- Conduct regular meetings with study teams and provide updates to stakeholders
- Coordinate with external vendors and partners involved in the trial
- Support development of key process initiatives and SOPs internally
- Oversee vendors supporting trial execution
Qualifications
- Bachelor's degree in Life Sciences, Nursing, or a related field
- Minimum of 7 years of experience in clinical trial management with a preference of leading Clinical Operations team (CRA, SSU, CTM)
- Experience in managing global oncology trials
- Strong understanding of GCP and regulatory requirements
- Excellent organizational and project management skills
- Proven ability to lead cross-functional teams and manage multiple priorities
- Strong communication and interpersonal skills
- Ability to work collaboratively in a team-oriented environment
- Flexibility and adaptability to changing priorities and workload
- Master's degree in a related field or clinical research certification (e.g., ACRP or SOCRA)
- Experience with electronic data capture (EDC) systems and clinical trial management software
- Prior experience in running or supporting Oncology clinical trials a plus
- Previous experience in a sponsor or CRO environment
Location/Travel
- Princeton NJ onsite in office
- Overnight travel ~25%
Requirements
- Bachelor's degree in Life Sciences, Nursing, or a related field
- Minimum of 7 years of experience in clinical trial management
- Experience in managing global oncology trials
- Strong understanding of GCP and regulatory requirements
- Excellent organizational and project management skills
- Proven ability to lead cross-functional teams and manage multiple priorities
- Strong communication and interpersonal skills
- Ability to work collaboratively in a team-oriented environment
- Flexibility and adaptability to changing priorities and workload
- Experience with electronic data capture (EDC) systems and clinical trial management software
- Previous experience in a sponsor or CRO environment
Benefits
- Medical, Dental & Vision
- 100% paid employee premiums
- Short-term & Long-term Disability
- 401(k) Matching
- 15 PTO Days
- Sick Leave
- 11 Paid Holidays
Company overview
SystImmune is a biotechnology company specializing in immune system research and therapeutic development. The company focuses on advancing innovative approaches to modulate and harness the immune system for treating various diseases. With a name suggesting systemic immune system targeting, SystImmune likely engages in research areas such as immunotherapy, autoimmune disorders, cancer immunology, and infectious disease treatments. The company operates at the intersection of immunology and biotechnology, developing novel therapeutic candidates that aim to address unmet medical needs through immune system modulation. SystImmune's research efforts contribute to the growing field of immunotherapies, which have revolutionized treatment approaches for cancer and other immune-related conditions. The company represents the cutting edge of biotechnology research focused on understanding and manipulating immune responses for therapeutic benefit.