Clinical Data Manager, Senior Study Lead Oncology
Contract
Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices. We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.
Overview:
- The Senior Lead Data Manager leads and/or supports the execution of data management activities necessary for the preparation of submission data and required documentation for regulatory authorities and the greater clinical research community.
- The Sr. LDM may assume the business role of a Study Data Manager in one or more clinical studies.
- In this capacity, she/he serves as the primary contact for Oncology Data Management on the Core Study Team.
- The Sr. Lead DM assumes operational and/or oversight responsibility as Study Data Manager for all assigned internal and outsourced studies, and applies Data Management best practices.
Duties/Responsibilities:
- Incorporates and maintains company standards in clinical studies and projects for all elements of the medical standards package.
- Documents all activities adequately for all assigned studies according to SOPs and takes a lead role in QC activities, which includes, but is not limited to: initiating the SDMD, maintaining document management systems, coordinating and ensuring contributions from relevant functions (i.e., EDC, CDC, etc.), requesting a timely QC of the SDMD, informing relevant functions of results and ensuring proper communication between functions, QC manager and self so that all issues are reconciled.
- Specifies and develops study specific eCRFs, database structures and data consistency checks based on medical standards, the Clinical Study Protocol and input from the study team.
- Prepares, tracks and implements standard plans (i.e., GDM Study Plan, Data Management Plan, Operational Oversight Plan, etc.) to ensure proper governance of data management study set-up, conduct and closure activities.
- Accountable for data management activities necessary for the establishment of subject validity and analysis set assignment, including but not limited to the following: specification of protocol deviations, planning and conduct of interim and final Validity Review Meeting.
- Supports study data management and data cleaning processes on an ongoing basis, applying study specific documents and conventions.
Requirements:
- Bachelor’s degree (or equivalent) in Natural Sciences, Informatics or Medical Documentation.
- At least 5 years of study and/or project level experience as a Data Manager in supportive and leading roles.
- At least 2 years of experience should demonstrate responsibility as a study leader.
- Good understanding of the drug development process.
- Strong organizational skills and able to collaborate with minimal supervision.
Key Experience Required:
- 5 to 10 years of experience – managing/hands-on Study Data Management.
- Study data with Oncology studies.
- Experience “start-up” of a study (multiple studies).
- Have led Oncology Studies.
- Oversight of studies.
- Prior experience should include as a Study Data Manager.
- Good to have SAS Programming – i.e., a very basic understanding/ability to do queries – this is not a hard requirement, but a Plus.
Preferences:
- Significant experience in using data management methodologies and technologies (e.g. data warehousing, electronic data capture).
- Demonstrated understanding of regulations and guidelines (e.g. ICH, GCP, European Clinical Trials Directive, Privacy rules [HIPAA], etc.).
All your information will be kept confidential according to EEO guidelines.
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