Senior Clinical Project Manager (Home Base)
USA – North America-United States. Please note candidates currently residing preferably in the following states but not limited of “AZ, MA, CA, CT, FL, ME, MD, NC, NH, NJ, NY, PA, RI, TX, VA, WV”
Serve as Sr. Clinical Project Manager (Home Base) for international projects Phase I, II, III, IV for Bio Pharmaceutical & Medical Device projects, according to ESTERN Medical Standard Operating Procedures, ICH Guidelines and GCP with total responsibility.
- Responsible for the successful conduct of assigned projects.
- Serve as Project Manager for assigned business development opportunities.
- Liaise with senior management in the Delivery and Service Centers to ensure adequate resources are available for assigned projects.
- Responsible for on time, on-budget provision of client deliverables for assigned projects.
Education / Qualifications:
- University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology).
- Detailed knowledge of financial control procedures
- Thorough knowledge of project management processes.
- Thorough knowledge of time and cost estimate development.
- Thorough knowledge of ICH Guidelines and GCP including international regulatory requirements for the conduct of clinical development programs.
- Excellent English and also preferably knowledge of some mid level Spanish or Portuguese language with superb grammar skills both written and verbal.
- Broad knowledge of drug development process and client needs.
- Masters or other advanced degree.
- Detailed knowledge of ESTERN Medical and the overall structure of the organization.
- Basic knowledge of ESTERN Medical sales and business development strategies and procedures.
- Thorough knowledge of ESTERN Medical S.O.P.s
- Minimum of seven (7) years relevant clinical research experience in a pharmaceutical / medical device company/CRO, including at least four (4) years of full project management responsibility.
- In lieu of the above requirement, candidates with > five (5) years supervisory experience in a heath care setting and > five (5) years clinical research experience including two (2) years of project management experience (international clinical trial management experience preferred) in the pharmaceutical or CRO industries will be considered.
- Experience in managing global (inter-continental) programs in a multi-office environment.
- Demonstrated ability to handle multiple competing priorities; utilize resources effectively.
- Financial awareness and ability to actively manage financial tracking systems.
- Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.
- Demonstrated ability to lead by example and to encourage team members to seek solutions
- Excellent communication, planning and organizational skills.
- Ability to work independently.
- Ability to negotiate and liaise with clients in a professional manner.
- Excellent computer skills with ability to understand and assess technology alternatives and implication for current processes.
- Therapeutic expertise, in Cardiovascular, CNS, Oncology, Ophthalmology, Infectious Diseases, Diagnostic Imaging, Pain Management and other.