Syneos Health

Manager/Senior Manager - IMP Logistics - UK

Location
Home Based, GBR
Salary
Competitive
Posted
08 Apr 2021
Closes
08 May 2021
Ref
21001730
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
LM/21001730
Manager/Senior Manager
IMP Clinical Trial Supplies
Home Based
UK


Here at Syneos Health we are currently looking for a Manager or Senior Manager to join our Clinical Trial Supplies team and to be based in the UK. The position provides customer-focused leadership in managing operational and financial aspects of clinical trial supplies management during the complete project life cycle.

Responsibilities for this role are as follows:

Project Leadership and Delivery
• Manages logistics of clinical trial supplies for assigned studies as an independent Clinical Trial Supplies Manager (CTSM); ensures compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), relevant standard operating procedures (SOPs), and regulatory requirements • Ensure operational delivery and financial performance of services assigned to the CTSM team
• Identifies clinical trial supply vendors; manages contracting of preferred vendors, as required
• Provides vendor management, inclusive of ensuring key Clinical Trial Supplies deliverables are met and financial parameters of contracts are upheld

Reporting and Communication
• Accountable for maintenance of project information on a variety of databases and systems
• Oversees the inventory, supply, and re-supply plans for subject kits and/or study medication required for the duration of a study and provides relevant reports for customers and management
• Develops and implements project plans in accordance with Controlled Documents and ensures proper archival of records in Trial Master Files to ensure inspection readiness

Business Development
• May participate in bid defence meetings for new business opportunities to articulate capabilities of the CTSM team and proposed strategies for management of clinical trial supplies logisticsEligibility/Qualifications/Requirements
The ideal candidate will need the following experience / skills to be considered:

• Associate's Degree (or equivalent) level of education, preferably focused on life sciences
• Experience in a contract research organization (CRO), pharmaceutical, or biotechnology company preferred
• Experience moving IMP between countries
• Knowledge of Good Clinical Practice, ICH guidelines, Good Manufacturing Practice, and other applicable regulatory requirements
• Proficiency with MS Office Applications
• Ability to travel as necessary (up to 5%)

We have a comprehensive benefits package and offer highly competitive remuneration.

If you have the required experience for this position and are eligible to work in the required location then please apply through our online application.

To find out more about our company and search and apply for other open jobs please visit our website https://www.syneoshealth.com/

Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most.

Disclaimer:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. #LI-LM1

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