Clinical Data Manager (Business Operations Senior Analyst) 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 day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease. |
We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
The Clinical Data Management (CDM) Business Operations Senior Analyst is an experienced professional in a matrix role within Clinical Data Management, reporting to the Head of CDM Business Operations. This position has focus upon activities and objectives that measure the internal quality and performance metrics as well as the external vendor (CRO) KPIs. In addition, as part of continuous improvement this position is responsible for assessing quality gaps and CAPA submissions, identifying isolated events from systemic issues and delivering improved process mitigation strategies and trainings. As a broader corporate initiative this role supports CDM's TMF/eTMF processes, currency, and compliance tracking for audit readiness. The role manages and maintains initiatives and actions regarding quality standards, process development, resource training, and performance metrics.
Major Duties and Responsibilities:
•Leads and/or participates in cross-functional CDM/Biometrics initiatives supporting Clinical Data Management processes and activities as assigned such as, but not limited to SOP management, internal metrics management, external vendor KPI tracking, and vendor and staff training,
•Monitors, administers, and assesses quality, performance KPIs, and consistency within CDM that are aligned with Medimmune strategies and standards across Biometrics and Clinical to ensure delivery excellence.
•Liaises with external departments such as Quality Compliance, Quality Assurance, Regulatory, Procurement, IT, Alliance Management, etc. concerning resolution of operational and scheduling/timeline issues in alignment with supervisor.
•Participates in the oversight of all CDM based CAPA assessments and responses; assists CDM project leaders in the execution of any associated actions.
•Collaborates with peers to assess process and design for CDM, eClinical Applications & Standards, Clinical Programming and Data Reporting, and Clinical Coding functions.
•May facilitate and/or represent CDM during activities associated with regulatory inspections/audits.
•Monitors industry developments within CDM space for consideration, planning and implementation.
•Leads and/or coordinates training programs (technical and professional skills) of new hires, existing staff, new SOPs, and function advancements to instill consistency and currency of staff.
•Develops and integrates clinical project standards and processes based on industry best practices
•Delivers change management for documentation and training of standards, process and technology while escalating valid change requests to the Standards Committee
•Provides CDM process expertise for Global Clinical Development Initiatives (Clinical, Regulatory and Drug Safety)
•Interacts with external vendors and customers on transactional engagements in communication and problem solving.
•Perform all other related duties as assigned.
•Education: Minimum of a BS in life sciences degree and/or equivalent experience
• Minimum of 5 years of Study Data Manager experience in the Biotech/Pharma/CRO industry
•Experience as a project manager of special initiatives supporting CDM activities.
•Experience in CDM process development
•Strong problem-solving skills with CDM process and experience on computer systems for Data Management.
•Strong understanding of clinical trial methodology, GCP, ICH and medical terminology
•Experience with major EDC platforms such as Medidata Rave
Special Skills/Abilities :
•Competent project management skills
•Excellent communication and interpersonal skills
•Knowledge of issues surrounding CDM activities related to clinical trials data
•Ability to work independently, under pressure meeting tight deadlines, demonstrating high level of initiative and flexibility.
•Excellent organizational and analytical skills
•High attention to detail and accuracy
•Proven problem and conflict solving skills
•Demonstrated knowledge of clinical and pharmaceutical drug development process
•Demonstrated understanding of Good Clinical Practices (GCP), Good Clinical Data Management Practices (GCDMP), and regulatory requirements as they relate to data management systems and activities
•Experience with clinical databases, clinical data management systems and electronic data capture (EDC)
•Demonstrated ability to work effectively with internal groups, external partners, and in a global team environment
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.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual 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 . AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.