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Manager, CTS

Greater Copenhagen, Denmark
BRIEF COMPANY PROFILE
The company is a global, research-driven pharmaceutical company focusing on the treatment of chronic diseases. The history dates back to early last century. Through the establishment of subsidiaries as well as mergers and acquisitions the company has become the world leader in their treatment areas.
 
THE POSITION
The Manager, Clinical Trial Supplies (CTS) will be responsible for managing the CTS team and the CTS function for all products and product candidates globally. Reporting to the Senior Director, Global Clinical Development, the role will act as “playing coach” – taking the leadership of the CTS team while supporting the team on assignments.   The Manager, Clinical Trial Supplies (CTS) will take a seat on the Global Clinical Development management team while functioning as an advisor and subject matter expert on CTS related activities.

The role will be responsible for allocating CTS resources to projects and tasks, and that SOP’s, working instructions and templates within the CTS area are maintained and updated. Additionally, the Manager will ensure continued collaboration across functional areas within Global Pharmacovigilance & Clinical Development and across sites.

The Manager is expected to provide supportive leadership, be forward-looking and set a clear direction for the CTS team. Moreover, the candidate must possess a strong knowledge of clinical development, GMP, GCP and GDP, and stakeholder management to effectively make sound decisions. Additionally, the ideal candidate must possess a strategic mindset and be a true team player with a focus on creating an open, inclusive, and collaborative work environment.
 
POSITION PROFILE
Position title:
 
Manager, Clinical Trial Supplies.
   
Reporting line:
 
Senior Director, Global Clinical Development.
   
Reporting to the position: 3 FTE’s
   
Location: Greater Copenhagen.
   
Traveling: Limited.
   
Responsibilities & Tasks:
 
Management Assignments
  • Managing the Clinical Trials Supply team including fulfilment of CTS commitments while facilitating a positive working environment and high satisfaction among employees.
  • Ensuring continued collaboration across functional areas within GPCD and across sites.
  • Allocating CTS resources to projects and tasks.
  • Ensuring vendor oversight of CMOs.
  • Managing the employee’s personal development and training, incl.:
    • Yearly appraisal/performance goals
    • In collaboration with the employees, planning of their training (courses and congresses).
    • Coach and develop employees
  • Ensuring that SOPs, working instructions and templates within the CTS area are maintained and updated.
  • Ensuring that CVs, job descriptions and other related documents for the CTS team in compliance with the quality system.
  • Participating in the GCD management team and extended GPCD management team activities
Playing Coach Assignments
  • Representing CTS in the Trial teams. Ensuring CTS requirements are met in the trial design.
  • Identifying the needed supplies for the trial based on trial synopsis, protocol, and input from clinical project managers. 
  • Planning and communicating the timelines for the full packaging and distribution set-up to relevant stakeholders.
  • Coordinating and being responsible for labelling, packaging, and distribution of clinical trial supplies for our client’s clinical trials.
  • Coordinating involved stakeholders (CMO, clinical teams and QA)
  • Preparing and approving required documentation in relation to packaging activities e.g. review of clinical trial protocols, preparation of packaging documentation, design and master labels etc.
  • Managing clinical trial forecasts and budgets.
  • Developing and maintaining required regulatory documentation e.g. Product Specification File.
  • Maintaining Quality documents e.g. SOP and WIN related to clinical trial supplies.
  • Managing handling of change control and deviations
   
Key success criteria:
 
  • Building and maintaining a motivated CTS team that is appropriately trained and developed to meet professional requirements.
  • Ensuring a collaborative team who can navigate smoothly among internal and external stakeholders.
  • Gaining a comprehensive understanding of the product portfolio and the disease area.
  • Successfully driving a high-performance culture, based on a proactive and pragmatic mindset focused on adding value in collaboration with stakeholders.
 
CANDIDATE PROFILE
Educational background: M.Sc. -level degree (or above) within Pharmacy or related fields.
   
Language: English – fluent (verbally and written).
   
Ideal experience:
  • 8+ years of experience with clinical development preferably from a Pharma/ Biopharma/ Biotech or CMO/CRO setting.
  • Broad theoretical and practical knowledge with clinical trial supplies for +5 years.
  • Preferably experienced manager or team leader.
  • Experienced IT user.
   
Personal & leadership competencies: Coaching/support
Actively trying to improve the skills and talent of the employees by giving positive and constructive feedback. Provides training and tasks with a view to challenging their skills and encourage development.

Planning

Plans a focused course of action for self and others, ensures appropriate project management and schedules an optimal use of the available resources.

Time management

Is agile and handles multiple priorities while being conscious of time in relation to work and effort. Plans tasks in relation to time spend and meets deadlines.

Collaborative
Builds bridges and works well with others with a view to obtain common objectives. Shares information; resolves issues and improve efficiency through strong stakeholder focus and management. Supports others and acts in a highly professional manner – seeing solutions rather than limitations.

Take control/responsibility
Possesses the courage to make decisions while making sure co-workers have a clear understanding of the direction of the tasks. Takes action, organizes resources and direct others toward successful execution. Drives projects forward to reach pivotal objectives, makes things happen and follows through.

Communication
Has excellent technical writing and verbal communication skills with a high level of proficiency in English. Produces written material that is clear, fluent, engaging and easy to understand. Has excellent cross-cultural communication and presentation skills and communicates the central issues in a discussion in a clear, fluent and precise manner, while being able to keep recipients' attention and is attentive to the needs of others when speaking.

Structure
Works systematically, organizes work and effort, is methodical in one's performance and holds on to commenced tasks and projects, specific problem, viewpoint or action plan until a result has been achieved or it is determined that an alternative approach is needed.
 

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