Business Title
Regional Clinical Project Manager
Requisition ID
EM-R-C- PROJ-M-1003
Job Category
Clinical Research
Locations
*Mexico / *Chile / *Colombia / *Argentina / *Brazil
Job Description
Serve as Clinical Project Manager for international projects Phase I, II, III, IV for 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
Required:
- 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.
- Fluent in English & Spanish, both written and verbal.
- Broad knowledge of drug development process and client needs.
- English & Spanish Written & Verbally.
Preferred:
- 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
Experience Required
- Minimum of seven (7) years relevant clinical research experience in a pharmaceutical 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, Diagnostic Imaging, Pain Management and other.
