BAP Pharma

Clinical Project Manager

Company
BAP Pharma
Location
Höchstädt an der Donau, Bayern
Salary
Competitive
Posted
12 Jul 2021
Closes
11 Aug 2021
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Company

BAP Pharma are Global Leaders in Clinical Trails supply, specialising in comparator sourcing and secondary packaging. Founded in 2011, BAP Pharma, is an incredible story of growth and success, steadily expanding its operations, with a presence in the UK, USA and Germany.

We are a team of professionals who have a passion for delivering on our promises to each other and our customers. We are driven to create exceptional value and an unrivalled service.  Our culture is one of openness, honesty, and respect. Our goal is to become a Global Leader in the Clinical Trails Supply Industry.

We are now looking for people with a passion for great customer service and doing the right thing, to help us take the business forward. Our people are our greatest asset, our future is exciting, come join us!

Job Description

BAP have an amazing opportunity for a Clinical Project Manager to join our busy and growing team. This position is responsible for working with clients to ensure the timely provision of clinical trial supplies by interpretation of study protocol specifications and utilisation of materials and procedures that meet study requirements.

Responsibilities include:-

  • Engages with clients to discuss the initial study packaging and labelling designs, resupplies and overall packaging strategy
  • Interacts with the business development team during the proposal writing phase for study design and specifications
  • Collaborates with the Project Associate in the preparation of preliminary layout drawings and packaging samples in compliance with the study protocol
  • Engages directly with clients to determine the specific requirements for each packaging operation
  • Responsible for checking calculations, appropriateness of components, correctness of proportions and other details to ensure accuracy
  • Responsible for creating material specifications for all incoming products
  • Oversees the sourcing of translations for label text, if required by the client
  • Manages the sourcing of booklet labels, if required by the client
  • Directs the label text approval process, including the creation of text within BAP Pharma’s label printing system and ensuring that clients have approved all necessary text approvals
  • Works with the Operations team in the randomisation approval process, including the outsourcing of randomisation codes for use in BAP Pharma’s labelling system and ensuring that clients have approved all the necessary randomisations
  • Performs the batch record creation process, including the creation of packaging samples
  • Initiates and develops all new card designs
  • Liaises with Operations and Quality Assurance representatives to further define requirements for packaging activities
  • Acts as a liaison between the clients and all internal departments for the requisition of any required documentation (i.e. MSDS, Certificates of Analysis, Client Authorisation etc)
  • Acquires materials for use in clinical studies, including cartons, labels, blister cards, bottles, closures, foil, film, comparator products etc
  • Collaborates with all departments to meet client timelines and coordinates activities between internal departments and clients
  • Communicates with external suppliers regarding sub-contracted services
  • Responsible for the final sign-off on the destruction of clinical labels
  • Responsible for the final sign-off on the disposition of any bulk or finished goods
  • Participates in client and/or MHRA audits, as required.

Requirements.

  • Relevant diploma or equivalent
  • Must be fluent in English with excellent written and verbal communication skills
  • German Language skills are essential
  • Excellent knowledge of all SOPs related to packaging and labelling
  • Familiarity with the pharmaceutical industry
  • Knowledge of EU cGMPs and GDP
  • Experience of working independently and in a team-oriented, collaborative environment is essential
  • Must work well with all staff by being persuasive, encouraging and motivating
  • Able to deal with changing priorities, demands and timelines through analytical and problem-solving capabilities
  • Present relevant material internally and externally, lead meetings and participate in training sessions
  • Must be able to learn, understand, and apply new technologies
  • Ability to effectively prioritise and execute tasks in a high-pressure environment Competencies
  • Excellent communication skills in English
  • Competent language skills in German
  • Excellent numeracy skills
  • Strong computer literacy skills
  • Interpersonal awareness and sensitivity
  • Results focussed
  • Attention to detail and thoroughness
  • Flexibility and adaptability
  • Maintain high standards of quality

This role reports to the Managing Director. Overtime may be required from time to time to meet project deadlines.  You must be able to sit for extended periods of time and have the ability to work under own initiative and as part of a team.  We have a diverse range of employees with different cultures and backgrounds and are committed to diversity and inclusion.

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