The Senior Clinical Project Manager plans and manages overall clinical operations for assigned global clinical trials/programs. This includes timelines, budgets, resources, investigational sites, vendors and key project deliverables. This position ensures compliance with SOPs, Regulatory requirements and ICH/GCP guidelines and aligns with Strategic & Innovation Group (SIG) strategies and goals. The Senior CPM may lead or mentor other CPMs in the organization.
Plan and Conduct Clinical Studies
• Lead and manage multidisciplinary Clinical Trial Teams to ensure all trial deliverables are met according to timelines, budget, quality standards and operational best practices.
• Serve as the primary contact with CRO and act as team leader of the study work group.
• Work with outsourcing manager to prepare clinical outsourcing specifications.
• Participate in the selection of CRO.
Quality and Process
• Contribute to and initiate process improvement initiatives.
Budget and Planning
• Establish project milestones, budget and timelines for the study in partnership with the study team and outsourcing manager.
Project Team Representative (PTR)
• Participate in the overall project planning and optimization with the Project Team.
• Work closely with the Medical Experts and Clinical Scientist for the design of the clinical trials within the program.
• Other duties as assigned.
Minimum Education, Knowledge, Skills, and Abilities
• Bachelor’s degree, preferably in a biologic/scientific discipline is required.
• Minimum of 7 years progressive experience in clinical operations including 5 years of clinical project management or equivalent with pharma, biotech and/or CRO is required.
• Systemic route of administration clinical trials experience required; pediatric, drug/device combination and biologics experience preferred.
• Thorough understanding of country-level regulations, ICH and GCP guidelines, cross-functional clinical processes including data management, biostatistics, medical writing, drug safety, and regulatory affairs.
• Vendor management experience preferred.
Working Conditions & Physical Requirements
The work environment characteristics and physical requirements described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing duties of this job, the employee may or may not be frequently/or occasionally required to:
· Stand; walk; sit; climb or balance; stoop; kneel; crouch; talk or hear; and taste or smell.
· Climb stairs or ride elevators.
· Lift and/or move up to 25 pounds.
· Use close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus.
· Manipulate keyboard or otherwise access computer, telephone and hand-held devices.
· Be exposed to outside weather conditions while going in and out of office buildings.
· Be exposed to moderate noise level usually in warehouse settings.
· Be exposed to moving equipment, mechanical parts, and/or high places; or moving between air-conditioned and non-air-conditioned environments.
· Travel is estimated at 30%.
Offices are in N. NJ and Dallas Tx
Will be required to be in office one day a week
PLEASE only apply is you have phase 1-4 clinical trials experience in the pharma, biotech or CRO industries