JOB SUMMARY:
The Project Manager (PM) is responsible for the initiation and tracking of assigned preclinical studies. The PM is essential for the success of the study project and will be responsible for study setup in Oracle, kickoff, budget, milestone tracking, revenue forecast and recognition, project cost confirmation, billing, and shipment coordination. The PM plays a central figure to the project and will interface with the customer, sales team, sales operations, finance, and study operations.
PRIMARY RESPONSIBILITIES:
1. Work with clients and Commercial team to initiate new projects and ensure all stakeholders are informed and contacted. Establish project in internal tracking systems and determine revenue recognition principle for each project type. 2. Serve as point of contact for client throughout the project life cycle and answer any administrative, logistical, study cost, and invoicing questions. 3. Track study progress with Operations team. Ensure and maintain accuracy of project budgets, forecasting, and timeline milestones.
Recognize project revenue in accordance with milestone and revenue recognition principles. 4. Work with the client, Operations team, and Commercial team on project scope changes and ensure client amendments are in place where necessary.5. Initiate invoicing by providing Finance team with appropriate documentation. Prepare, confirm, and provide final cost summaries for the client prior to project close out.6. Respond to audit requests from internal and external financial auditors and Quality team.7. Prepare ad-hoc reporting as requested by Site or PM management.8. Complete all required training and actively participate in group meetings with global PM team.9. Special projects as assigned by manager.10. May serve as Account Manager responsible for collecting data from global PMs, participating in client calls, and generating monthly key account reports11. May serve as Program Manager for CBSD Clinical Biomarker.
Minimum Requirements
- Bachelor's degree or equivalent, in a biomedical, life science or related field of study.
- Two or more years of project management or clinical operations experience for with increasing levels of responsibility, in the Pharmaceutical, Biotechnology, Medical Device or CRO industry is required.
Preferred Qualfications
- Masters Degree and two or more years or bachelors degree and four or more years of experience of project management or clinical operations experience in the Pharmaceutical, Biotechnology, Medical Device or CRO industry.
- CRO experience highly desired.
SKILL REQUIREMENTS:
- Comfortable using computers, including an advanced knowledge of the Microsoft Office suite, e-mail, and internet
- Exceptional organizational, time- management, and prioritization skills
- Able to multi-task with a high degree of professionalism and diplomacy
- Willing and able to work within a Quality System with oversight by QA and other regulatory bodies
- Able to find, read, and understand relevant scientific literature
- Willing and able to work under the pressure of deadlines and find solutions to meet timelines
- Able to work across teams by being a flexible team player
- Strong communication and interpersonal skills
- Good understanding of project management process and concept
WORKING CONDITIONS and PHYSICAL REQUIREMENTS:
- Sitting for long periods of time
- Prolonged computer usage
- Able to lift up to 20lbs
- Normal office environment
This is a hybrid position.
