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Sr Study Manager, Logistics & Clinical Supply (LCS)

Location Gaithersburg, Maryland, United States Job ID R-070841 Date posted 01/12/2020

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration through scientific research. Here, employees are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity.

We are seeking a Sr Study Manager to join the Logistics & Clinical Supply (LCS) team in a full time office based role in Gaithersburg, MD

Position Summary

  • Provide oversight for Study Management activities within Logistics and Clinical Supply (LCS). 
  • Independently plan, manage and deliver all aspects of Investigational Medicinal Product (IMP) supply for assigned clinical studies.
  • Work collaboratively within LCS and with all other interfaces and stakeholders internally and externally as required to ensure highly effective clinical supply planning and execution. 
  • Apply skills and knowledge to advise and develop improvements appropriate to enable ongoing seamless and efficient Study Management practices within LCS
  • Play an active role in the operational leadership of the LCS team

Major Duties and Responsibilities

  • Provide general oversight for Study Management activities within LCS ensuring highly effective planning and management of IMP supply for clinical studies.   
    • Play an active role in technical management of LCS Study Managers, including technical direction / support and input to definition of robust Study Manager assignments.
    • Where necessary ensure project continuity through key transition events and staff absences
    • As required provide direct oversight and supervision to specified studies managed by other members of the Study Management group
  • Independently plan, manage and deliver IMP supply for assigned clinical studies.  A Senior Study Manager will typically have direct responsibility for management of multiple studies involving diverse development compounds and/or external collaboration based studies as required.  Studies may be domestic and /or international in scope and will include complex operations such as associated with later phase clinical trials, or in provision of Auxiliary Medicinal Products (AMP)
    • Influence, own and promote functional deployment of tools and procedures to create documentation required to support IMP supply activities
    • Ensure that Study Manager input into study related documents and activities is relevant, accurate and timely. 
    • Provide oversight of the activities related to processing of product complaints, non-conformances, product recalls or enquiries pertaining to assigned clinical studies
  • Throughout each project lifecycle, promote and ensure maintenance of current, accurate and complete IMP related study documentation (hard copy and electronic as appropriate).  Enable that all necessary files are uploaded in a timely manner to the Trial Master File (TMF), appended to the Product Specification File (PSF), or made available within other relevant GXP system as required. 
  • Maintain and expand close cross-functional relationships while proactively seeking information pertaining to clinical studies to best design, plan and implement Study Management activities for all relevant projects
  • Collaborate within LCS to ensure highly effective matrix working including closely   coordinated delivery of Study, Vendor, Distribution and Systems management activities for each relevant study.   
  • Ensure Study Management representation of Vendor, Distribution and Systems management activities at the Supply Continuity Team (SCT).
  • As a member of the SCT contribute to and influence the development /supply strategy, ensuring that the demand, risks and opportunities for supply optimization are discussed
  • Enable creation, maintenance, and clear communication of supply strategy and aligned dynamic long range project demand forecast for assigned clinical studies.
  • Liaise closely to ensure clear transfer of information to the Vendor group responsible for management of the study budget
  • Represent LCS as an engaged and active participant at the Clinical Trial Team (CTT).  Ensure clear information exchange in relation to current supply activities and influence for effective and timely consideration of any change scenarios that may impact supply plans.  Provide dynamic interface with the SCT to ensure on-going responsiveness to any factors that may impact supply strategy, aligning planning and implementation of any agreed changes
  • Liaise closely with Quality Assurance (QA) to ensure that all Study Management activities are conducted in accordance with cGMP, GCP, & ICH guidelines
    • Initiate non-conformances when identified and complete investigations to support on time closure of Trackwise records
  • Partner with stakeholder departments (e.g. Quality Assurance, Analytical, clinical and Regulatory) to develop, communicate and deliver a risk mitigated supply strategy.  Ensure that any issues relating to IMP release and supply to the clinic are highlighted and that solutions are provided for the project and for other similar projects in Development. 
  • Influence and enable development of optimal working practices, SOPs, systems and tools, to ensure robust Study Management execution and stakeholder communications.
  • Apply skills and knowledge to advise and/or develop improvements and future growth opportunities ensuring that LCS Study Management working practices are well aligned to business requirements
  • Support analysis and advise on development of Study Management scope and activities to improve efficiency and enable robust interfaces and/or execution
  • Lead departmental process improvement initiatives as required
  • Actively engage in the creation and maintenance of LCS department SOPs and aligned guidance documents or other work instructions and training materials.  Ensure procedures are maintained as accurate, enterprise aligned (where required) and reflective of current best practice.
  • As a member of the LCS Senior Management team, play an active role in operational management of the group, including deputizing for other managers as required
  • Represent LCS in cross functional initiatives of moderate business impact, such as would benefit the design and establishment of organizational processes
  • Apply own unique training and expertise to deliver against flexible assignments within other LCS roles
  • Mentor, develop and supervise the daily activities of LCS staff acting either as Technical Manager or in relation to matrix team members.  Enable through others highly effective Study Management, team working and overall supply strategy and delivery
  • As required act as Line Manager for LCS staff enabling delivery through direct reports and advancing employee engagement and development
  • Communicate seamlessly within assigned teams, and with all interfacing functions and relevant groups as required.

Requirements/Qualifications

Education

Requires a Bachelor’s degree in basic/ applied science or engineering, and may have a higher level qualification such as a Master’s degree.  The Senior Study Manager will have appropriate direct experience in a development or technical operations environment in the biopharmaceutical and/or health care industry.  Specific experience in delivery of international clinical studies, with focus on IMP supply & management is required. 

Minimum Education Requirements:

  • Bachelors degree in basic/applied science or engineering and a minimum of 12 years of relevant experience
  • Masters degree in basic/applied science or engineering and a minimum of 10 years of relevant experience

  • PhD / PharmD and some experience preferred

Experience

  • Substantial experience in planning and delivering all aspects of IMP management for complex clinical studies, including oversight of vendors performing GMP operations. 
  • An excellent understanding of cGMP, GCP and ICH guidelines as related to IMP management. 
  • Broad knowledge of biopharmaceutical product development and demonstrated ability to achieve results in a cross-functional, multi product environment
  • Direct experience in managing IMP supply to global trails in the biotechnology industry is strongly preferred.
  • Experience managing people (either as line or matrix manager) preferred, with proven ability to work in a dynamic environment and collaborate within cross functional project teams.
  • Ability to work in a dynamic environment, and collaborate effectively within cross functional teams to deliver complex projects

Special Skills/Abilities

This position requires a high level of commitment, flexibility, initiative and independence, with strong skills for planning, coordination, teamwork, communication and interpersonal relations.  The Senior Study Manager will be highly organized and have strong analytical skills whilst demonstrating keen attention to detail, aptitude for technical troubleshooting on issues relating to IMP supply, and appropriate tact and diplomacy in building/managing interface relationships.

Job Complexity

This is a complex and highly interactive job requiring excellent communication and influencing skills, combined with demonstrated technical aptitude.  The position requires an individual who can coach, train and promote positive morale amongst their teams.  The Senior Study Manager is able to work effectively through both formal and informal networks and to operate with a high level of independence whilst maintaining an appropriate information flow to stakeholders.

Supervision

It is expected that the Senior Study Manager will operate with a high level of independence and has latitude in determining technical objectives of assignments.Work is monitored for technical and scientific judgement and achievement.



AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.

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Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.