Clinical Project Manager
Integrium is a full-service (CRO) Firm focused on drug and device development within the therapeutic areas of Cardiovascular, Metabolic, Renal, Inflammatory, Dermatology, Wound Healing, Regenerative, and Orphan Diseases.
Integrium is looking to hire a Clinical Project Manager to work remotely, with occasional travel to our California or New Jersey office. He/she will provide customer-focused leadership in managing multiple Phase I through Phase IV clinical research trials across the functional areas of study start-up, site selection, overseeing CRA monitoring, patient recruitment, database lock and study close-out. This position is accountable for the successful completion of all assigned projects, where success involves managing the global project timelines, tasks and budget and presenting regular analytical and metric reports regarding the project’s status to Clients and to management.
Education and experience required:
- BS/BA, is a must, RN preferred, but not required.
- Experience working for a CRO.
- MUST have site monitoring experience/CRA experience.
- 5+ years of clinical research/project management experience.
- Knowledge of GCP regulatory requirements.
- Knowledge and a clear understanding of the overall drug development process.
- Experienced in negotiations, client guest relations and project specific risk assessment skills.
Essential job functions:
- Coordinates project organization, implementation and management activities between all Integrium operations and the client. Serves as the primary client contact at the project operational level.
- Manages scope of work and timeline and budget expectations from study launch to study completion, assessing and verifying adherence to the projects’ actual versus projected study metrics.
- Prepares the Project Plan including a timelines and communication plan and implements alternative solutions to problems with study timelines, schedules, resources, budgets, etc. for the projects for which he/she is accountable.
- Reports regularly on study progress, issues and scope of work considerations to Director Project Management.
- Observes strict adherence to company and/or Sponsor Standard Operating Procedures (SOP) and corporate policies.
- Determines resources, priorities, and verifies completion of all individual tasks per timeline in coordination with appropriate team members.
Additional skills and abilities:
- Excellent verbal and written communication skills.
- Exceptional organizational and time management skills.
- Ability to work independently.
- Excellent problem-solving skills.
- Strong attention to detail and accuracy.
- Strong commitment to quality.
- Must be customer oriented and flexible.
- Ability to travel domestically and internationally as required and process visit reports and expense reports effectively.
- Approximately 25% travel required.
We also provide an exceptional benefits package that includes:
- Vacation Pay, Personal Time and Sick Time
- Health insurance (PPO, HSA)
- Dental and Vision plan
- Prescription drug plan
- Life & AD&D
- Short-term Disability
- Long Term Disability
- 401(k) Plan
Equal Opportunity/Affirmative Action Employer
Integrium, LLC. is an equal opportunity employer and promotes a work environment where diversity is embraced.