If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions - join us.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. As a Clinical Data Management Project Lead - Clinical Data Reviewer in Gaithersburg, MD
you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
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.
Main Duties and ResponsibilitiesAs the Clinical Data Management Project Lead (DMPL) - Clinical Data Reviewer, you will provide leadership and functional area expertise in the strategic planning and delivery of Clinical Data Management (CDM) deliverables at Study
Level. Oversees the Functional Service Providers or in-house teams by managing, prioritizing, and ensuring compliance to MedImmune global and project standards. Forecasts data management workload based on corporate pipeline and priorities. Manages vendor contracts and Service Providers budget. You will serve as the expert in Clinical Data Management to provide oversight and advice to the clinical project team regarding the CDM activities and deliverables. Point of Contact for all DM deliverables for clinical trial teams, external data vendors and Functional Service providers. Manage and resolve issues related to DM deliverables by developing solutions to complex problems to ensure consistency across organization; provide options to leadership or own the decision per study needs after a thorough due diligence. Create and own the Study timelines (Project Plans) for data management deliverables. Proactively identify & manage risk mitigation for the timelines & quality deliverables around Database Go live, Migration and Locks. Ensure compliance to TMF/eTMF archival requirements. Author, review various Data Management documentation ex: Data Management Plan, Data Review Plan, Data Validation Plan, eCRF completion guidelines etc...
You will develop clinical project standards and processes based on industry best practices. Ensure that the Global and Therapeutic standards are enforced at all stages of a clinical trial & adhered by the clinical trial teams. Work independently with study teams to understand and explain standards, while escalating valid change requests to the Standards Committee. May be asked to take on a global standards role as a member of the Standards Committee. Management and oversight of vendor contracts, resourcing and budgets.
You will lead and manage FSP delivery against KPIs and overall FSP performance. Initiate contract process for the CDM vendor and provides study team with estimated costs. Scope out budgets/costs associated with Data Management activities supported by FSP Vendors. Responsible for Service Order/Purchase Order creation and maintenance by managing periodic invoices. Deliver or receive effective customer feedback to FSP and project teams.
You will standardize and harmonize the procedures around management of external and electronic trial data (ex: labs, IxRS and ECG, ePRO); to review and establish electronic data project standards and procedures. Lead, Coordinate and/or perform reconciliation of external data transfers and EDC system data. Lead and maintain the completion of Data Transfer Agreement and receipt of data from the external laboratory and other electronic trial data. Engage directly with the external laboratory for reconciliation of discrepant observations between the transferred data and EDC system data. Effectively contribute to standardized and harmonized procedures, database structures, naming conventions, code lists etc. for global database. Effective Collaboration to maintain the local laboratory system parameters, units, conversion factors, laboratory names, and reference ranges. Ensure adherence to standard database structures, naming conventions, code lists concerning the laboratory/electronic data by the clinical trial teams. Effectively engage with other functional areas and external data vendors to ensure that harmonization and standard procedures are followed. Review all trial protocols, including CRFs with respect to laboratory and electronic data and translate that into effective project deliverables.
You will regularly review of clinical trial data and identify trends and issues and corrective actions. Lead and facilitate the data review meetings with key clinical trial team members and track progress on cross functional patient data cleaning and data review. SME on clinical data review from Data Management point of view and mentor and train the DM team to effectively lead and facilitate data review meetings. Lead and manage the development of specifications and UAT on the outputs for specialized/Smart listings for review of data. Lead the efforts in process optimization in clinical data review by gathering insight and adapting from Industry experts. Ensure real time data review to ensure data cleanliness to support timelines reductions and effective regulatory submissionEssential Requirements
- Minimum of a BS in life sciences degree and/or equivalent experience.
- Minimum of 8 years of Data Management experience in the Biotech/Pharma/CRO industry.
- At least 2 to 4 years of relevant Clinical Data Review experience.
- Working knowledge of JReview, Spot fire and any other data review tools - preferred.
- Ability to draw conclusions based on data and recommend corrective actions.
Next Steps - Apply today!
- Demonstrated knowledge of clinical and pharmaceutical drug development process.
- Demonstrated current understanding of GCP and regulatory requirements as they relate to data management systems and activities.
- Demonstrated current understanding of Good Clinical Data Management Practices (GCDMP).
- State of the art understanding of database structures, data standards (CDISC) and practices as they apply to CRF design, database development, data handling and reporting.
- Experience of clinical databases, different clinical data management systems and electronic data capture (EDC).
- Demonstrated understanding of clinical data system design / development / validation and system interoperability.
- Demonstrated leadership (including in an outsourced environment).
- Demonstrated project management skills.
- Strong communication and interpersonal skills.
- Excellent organizational and analytical skills.
- Ability to work independently.
- Demonstrated ability to work effectively with external partners.
- Ability to negotiate and influence others across functional areas.
- Excellent written and verbal communication skills.
- Effective problem and conflict solving skills.
- Ability to work in a global team environment.
- Ability to interact effectively with all levels of management.
- High attention to detail and accuracy.
- Extensive knowledge of Medidata Rave EDC Lab Module including definitions and maintenance of labs, lab parameters and associated reference ranges.
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.