Clinical Supplies Manager – Global Lead

Salary: £24.24 per hour

Our Client is an independently owned and operated company that works exclusively with clinical trial materials. The UK site provides secondary packaging, labelling and distribution of clinical trial supplies for sponsor company organisations. Their facility serves as the packaging and distribution hub for clinical trial materials to Europe and the rest of world.

Due to continued growth, they are now seeking a Clinical Supplies Manager – Global Lead to join their dynamic team. This position is a full-time permanent role and location within the UK is flexible. (Remote working)

Job Purpose

The Clinical Supplies Manager – Global Lead is responsible for providing Global Operational Leadership and proactive Client Relationship Management to clients for services and operational activities

Key Areas of Responsibility

* Primary contact from initial set-up activities and throughout the duration of the global clinical studies for Sponsor and internal teams across multiple services areas. Ensure the trial is effectively supported and of the high standard expected

* Work with a variety of clients on different clinical studies requiring a proactive and flexible approach. Ensure appropriate level of support to global clinical studies. Ensure deliverables are met and a successful partnership is developed and maintained by sponsor

* Manage and lead strategic operational aspects of clinical trial projects to ensure timely and coordinated delivery. Provide senior level consultation and support internally and to the sponsor. Update BD on potential future studies (business intelligence)

* Lead communication between multi-functional teams to define and monitor project milestones and achieve overall project alignment. Drive continuous improvement and identify optimal processes for specific partnership opportunities. Development and reporting of customer KPIs

* Provide support for quote and invoicing activities. Take a proactive role in change order management on those studies to which GPM is assigned.

* Manage issues and lead effective resolution with sponsor. Preparation and management of a project plan to meet required milestones

* Lead meetings with sponsor and internal teams to facilitate project completion. Deliver project within agreed timelines and budget.

* Manage projects that may reside within single or multiple point of contact for the sponsor and facilitate responses to sponsor questions and observations

* Primary client communication focal point for project team and client advocate. Take on additional assignments for the department, group, or site with support

* Conduct issue resolution activities for supply aspects of clinical studies (e.g. packaging, distribution). Track global projects as assigned internally between the US and UK facility

* Provide support and assistance for sponsor requiring Qualified Persons release/certification of supplies

* Create overall draft timelines pre-proposal to destruction. Generation and upkeep of pertinent sections of CSPL with the understanding that this is a jointly owned document requiring input from all departments

* Responsible for initiating client kick-off meeting and subsequent internal kick-off meetings as required

* Develop close-out strategy for study. Provide visibility of progress to internal and external stakeholders

* Provide notification of milestone completion to finance for billing

* Liaise between sponsor and QP for early information gathering for QP Declaration

* Establish and or confirm the client Project Management / Clinical Supplies Management support needs

* Responsible for compiling and issuing the communication plan / charter / for setting up routine meetings with Client / for setting up internal meetings as required / for compiling, issuing, and storing meeting minutes / for escalation of points of concern regarding timing / contractual issues

* Create and share study Dashboard with Client / internal management / Take part in business review meetings with Client / Understand and where possible incorporate the client’s needs into proposal activity

Qualifications and Experience

* Degree or equivalent work experience

* Solid Pharmaceutical Clinical Supply Management or related experience

* PMP / Prince2 certification desirable

* Effective experience in project management to include global clinical trials, experience with IRT systems, packaging and distribution

* A thorough understanding of GDP/GMP guidelines

* Experience in using drug supply forecasting systems desirable

* Attention to detail

* Strong listening and communication skills

* Ability to lead teams across time zones and functions internally and externally

* Strong sponsor relations and interpersonal skills

* Strong working knowledge of MS Office

In return our client is offering a competitive basic salary plus benefits for the successful Candidate. (Salary is negotiable dependent on experience).

Please send your C.V to Lorraine Roger, Director at Atom Recruitment Ltd.