This position will be based in California and initially, will not have any direct reports.
- Designs, writes and reviews sample collection study protocols, negotiates collection study contracts, facilitates purchase requisitions, and collaborates with suppliers to acquire biological materials of interest to RMD's projects, in compliance with Good Clinical Practices, Good Laboratory Practices, Quality, Business, and Industry best practices/standards.
- Collaborates with User Groups across client company's Projects and Functional Areas to ensure that customer requirements for biological materials are agreed to, via formal established processes, communicated to on a periodic basis, and met per commitment.
- Collaborates with client company's internal/external clients and service providers to establish and monitor compliance with the sample collection protocols, including, but not limited to, the collection and maintenance of legal and regulatory documentation, ethics committees approvals, accurate and complete data set, facilitating operational permits, managing material logistics, and maintaining collection study information in a validated laboratory information management system per Good Clinical Practices and Quality Standards.
- Engages, establishes, and manages suppliers to actively support client company's biological material/process requirements. Monitors sample collection studies, identifies and resolves discrepancies associated with sample collection projects.
- Participates in Project Team Meetings and provides periodic updates on sample collection projects.
- Establishes and maintains strategic metrics (Key Performance Indicators), and monitors performance.
- Establishes and maintains effective working relationships with BSM members within/across service locations to manage service requests and associated process requirements efficiently. Mentors and provides guidance to junior associates.
- Maintains a working knowledge of regulations, scientific literature, and client company's product portfolio.
- Maintains a self-managing, organized and detail-oriented disposition, with good writing, analytical, technical and interpersonal skills, to work with internal/external biological material customers, collaborators, and suppliers, such as, thought leaders and key customers in the medical community across the globe, while representing client company in a professional manner.
- Personal Characteristics & Cultural Fit
- Excellent networking skills and experience.
- Flexibility with respect to projects, unique specimen requirements, and meeting client/organizational goals and expectations.
- Excellent written and verbal communication skills, as well as the ability to present information to a wide range of audiences.
- Ability to teach and lead others.
- Ability to work in a fast paced and dynamic environment with efficiency; and capable of handling multiple projects.
- Truly passionate about the importance of specimen management, as well as the ability to lead and motivate others, particularly in a global, matrixed environment.
- Excellent cross-functional team leadership and participation skills.
- Results and goals oriented.
5+ to 7 years experience
-High critical thinking skills-This person finds very specific specimens from donors across the globe-High level of client service interfacing with internal and external stakeholders-Vendor management and specimen procurement-Leadership experience preferred-Ability to influence with strong communication skills