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We Are PRA.
We are 15,000+ employees strong, operating in more than 80 countries. We are committed to saving lives and we are constantly striving to be the best at what we do. Our impact is real and we see it every single day. We help get life-saving drugs into the hands of those who need them most.
Works in partnership with the scientific, business, operational, clinical and technology areas to support the execution of global clinical trials in the area of global clinical supply management. This includes management of the planning/forecasting, packaging/labeling, distribution and return of clinical supplies for phase 1-IV clinical trials.
Responsibilities may include:
• Manage clinical supply planning and forecasting for study protocols, with focus on less complex study designs
• Serve as member of clinical study team and/or clinical drug supply team, as assigned
• Interpret relevant protocol information to develop packaging/labeling design and/or global distribution strategy
• Coordinate the origination, proofing and translation of clinical study labels, as required
• Support design and set-up of IVRS system
• Support financial planning for global clinical supplies, including budgeting, forecasting, and strategic planning activities for clinical trials and pharmaceutical development pipeline
• Manage drug supply delivery timelines with Clinical, packaging source area(s), and indirectly with GMP laboratories, QA and Regulatory Affairs, as required
• Prepare required documentation and assist internal and external stakeholders to facilitate activities for the import and export of clinical supplies, as required.
• Maintain close communications with all internal-chain groups to ensure the adequate supply of clinical supplies throughout the duration of a clinical trial
• Monitor global clinical supply inventory for both IVRS and traditional studies via tracking of specific milestone dates and adjusting drug distribution plan accordingly
• Resolve issues involving distribution of clinical supplies, including US & International shipments, temperature excursions, etc.
• Manage clinical supply complaints received from investigative sites and/or subsidiaries, address supply replacement requests.
• Monitor expiry dating for clinical study supplies.
• Interact with other departments, as needed, to resolve any issues involving clinical supply inventory and distribution. .
• Ensure that all tasks meet Sponsor and PRA expectations, and are delivered in accordance with the contract, trial protocol, ICH/GCP and applicable SOPs.
• Coordinate procurement activities for comparator, other NIMP and/or ancillary supplies
• Manage clinical supply planning and forecasting for study protocols with more complex study design
• Participate in implementation of improvement initiative(s)
• May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines
• May mentor junior level Clinical Supply Managers and serve as a resource for new employees
• Minimum 5 of years relevant work experience.
• A Bachelor’s degree in health sciences or related field is highly preferred
• 5-7 years of prior experience in a pharmaceutical, biotech and clinical supply logistics environment preferred
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.