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Manager, Direct to Site Services
- Permanent
- Good Manufacturing Practice (GMP)
- United States
This vacancy has now expired. Please see similar roles below...
Proclinical is currently recruiting for a Manager of Direct to Site Services for a pharmaceutical company located in Norristown, PA. Successful candidate will manage the team in the US to support the needs of any project that requires services and oversight from the DTS group. Candidate will have regular communication with clients and will also directly manage a team of Project Managers/Associates.
Job Responsibilities:
- Oversee all activities of the DTS team in the US; oversee DTS PM's and associate's tasks to support accurate procurement, labeling, and distribution activities.
- Hire, develop, manage and lead a team of DTS Project Managers/Associates to meet the needs of the company and our clients.
- Interact with clients to ensure satisfaction and build long-term relationships.
- Create and maintain Key Performance Indicators (KPI's) for the DTS US department.
- Work closely with clients to determine clinical trial requirements and develop appropriate supply strategies, project timelines, and projects plans to meet the client's study needs.
- Generate proposals / budgets which accurately reflect the needs of the clinical project.
- Interface with appropriate external customers to successful deliver the client's product requirements in a timely and cost-effective manner.
- Manage the development of departmental procedures and staff training plans.
- Create accurate invoices and alert the finance team when appropriate.
- Coordinate closely with the client in the pre-project planning phase to define the requirements (documents, drug products, forms and/or labeling, if required). This includes creating protocol specific Label Proofs, Batch Records, Distribution Instructions, Drug Shipment Request templates, and other study documentation.
- Coordinate with internal departments to ensure appropriate drug is procured for the client, ensuring t activities are performed in accordance with client expectations, appropriate industry regulations (EMEA/Home Office/FDA), and industry accepted Quality standards.
- Manage both internal and outsourced packaging and labeling activities including project setup, communication of client requirements, sourcing of labels and other packaging supplies as needed, management of material flow, and coordination of batch record review and release.
- Support the growth of new services lines in support of clinical trial services.
- Participate in GMP labeling and distribution activities, as needed, based on workload and resource availability (Activities will occur in both the ambient and 2-8C environment).
- Collaborate with peers to drive process improvement.
- Attend industry events/conferences in support of new business development and enhancing existing client relationships.
Skills and Requirements:
- Bachelor's Degree or equivalent experience.
- 5+ years' experience in the clinical supply field; experience in labeling and/or distribution preferred.
- Experience in leading project management teams preferred.
- Ability to be flexible, work as part of a team, and manage multiple projects simultaneously.
- Ability to adapt to different client needs and to develop and maintain successful working relationships.
- Good numerical competence in order to analyze facts and figures.
- Ability to make important decisions and cope with the pressure of demanding targets and tight deadlines.
- High attention to details.
- Analytical skills and problem-solving abilities.
- Intermediate or higher skill level in Microsoft Office Suite.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Ysabel Capitan at (+1) 347-293-1123 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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#QualityAssurance
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