Clinical Sampling Project Manager job in Gaithersburg
|Employer:|| AstraZeneca Pharmaceuticals|
|Category:||Research and Development|
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every single day. We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a real passion for discovery and a pipeline to show for it. We're pioneering creative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular, renal and metabolic disease as well as advancing innovative trial design and digital health. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore alignments between small and large molecules MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture talent providing extensive opportunities for development within MedImmune and AZ.|
Within our Clinical Services group we are recruiting for a newly created position: Clinical Sample Project Manager (CSPM), therefore there is significant opportunity to grow and tailor responsibilities as the role evolves. This is a full-time office based position and can be based in Cambridge UK, or Gaithersburg, US and will support Clinical Operations globally.
In the role of CSPM, you will be responsible for leadership and performance oversight manager of laboratory services in Clinical Biologics at MedImmune. You will act as subject matter expert (SME) in the delivery of laboratory related activities in early phase global development projects, including biomarkers, central safety and clinical bioanalysis. You are expected to collaborate with key partners within Clinical, Translational Science, Outsourcing, CRO partners and external central laboratory partners to assimilate sample management standard methodologies and training.
In addition, you are responsible for oversight and project management of Biospecimen Scientist (BSS) to ensure quality and timely project delivery of MedImmune clinical studies.
Major Duties and Responsibilities:
•Lead BSS Oversight and Management Team
•Develop and maintain clinical sample tracking processes, Key Performance Indicators and standards
•Serve as Clinical Sample Management and Tracking SME providing consultation to Biospecimen scientist (BSS) and Clinical Trial Teams (CTT)
•Monitor and maintain established processes and standards, lead continuous improvement initiatives with Clinical, Translational Science, central laboratory partners, sample tracking system owner and data management
•Sample Tracking System liaison;
•facilitating preparation of documentation to support "good use"
•lead/contribute to the on-boarding meeting, partners understand/document system requirements to support sample lifecycle
•participate in the definition and prioritization of system enhancements, and process improvement for user communities
•Identify quality issues as they arise ensuring management, escalation, CAPA development and mitigation of future risk, provide support during audits and inspections.
•Work collaboratively with sample management specialists in TS/TM, AstraZeneca GMD and ECD to ensure where possible harmonization across the enterprise, highlighting and managing differences where necessary
•Actively position MedImmune as an innovator in sample management and quality standards Constantly seek opportunities for improvement of digital/innovative methodologies with a focus on working across CTTs to facilitate incorporation of a patient centric design in clinical trials
•Develop partner communications, standard methodologies lessons learned, and training.
•Provide consultation to CTT/CST in development of key documentation including:
•protocol schedules of events in order to minimize costs and ease patient burden
•leading teams in addressing operational considerations pursuant to MedImmune laboratory partnership models
•defining technical specifications, sample management and oversight plans, and scopes of work
•selecting and setting up laboratory relationships
•facilitating processes around bio banking and logistics
Bachelors of Science degree in related discipline, preferably in medical or biological science, or equivalent work experience in directly related fields of endeavor.
Other Skills and Qualifications:
•Experience in clinical development, as well as an understanding of GCP and GCLP, required.
•Demonstrated aptitude for process and technology; experience with process and training design and implementation
•Hands-on experience in a clinical laboratory setting or clinical research site
•Proven leadership experiences (people and project) including team facilitation skills and extensive collaborative communications in a matrix organization
•Proven project management skills, excellent written and verbal communication skills
•Proven negotiation, collaboration, interpersonal, problem solving and conflict resolution skills
•Ability to effectively lead complex process and technology projects in cross functional environment
•In- depth knowledge of Good Clinical Practice (GCP) and validated systems and company procedural documents, as they pertain to clinical operations systems and processes
•Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in cross functional environment
•Positive change management skills across individual, team and business parameters-- viewing change as an opportunity to improve performance and make valuable contributions to the business
•Demonstrated professionalism, diplomacy, mutual respect and the ability to manage/value diversity and cultural differences and promote productivity through encouragement
•Demonstrated customer focused results and drive performance driven.
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
MedImmune is an equal opportunity employer. MedImmune will consider all qualified applicants for employment without discrimination on grounds of disability, gender or gender orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.
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