Must sit onsite, Minimum 5 years of Data Mgt Lead exp at a Pharmaceutical company. Must have extensive CRO/Vendor mgt experience.
The Clinical Data Manager is an individual contributor performing complex data management tasks independently throughout the full lifecycle from study start-up through database archive. This includes oversight and collaboration with CROs and crossfunctional teams for protocol review, database design specifications, validation, maintenance, and data cleaning. The position reports to the VP Clinical Science Operations and Clinical Quality.
These responsibilities include:
Oversee all data management activities for assigned studies performed by CROs
Function as study DM liaison with cross-functional team members, both internal and external, to ensure quality on-time data management deliverables.
Oversight of CROs/vendors to ensure efficiency, quality, and consistency for all data management deliverables across assigned study or program
Represent Data Management at assigned study team meetings including Kick off meetings, lessons learned meetings and close-out meetings.
Oversee and collaborate with CROs in development of Data Management documents including DMPs, eCRF Completion Guidelines, eCRFs, DTA/DTS
Create, manage, and execute User Acceptance Testing (UAT) Plan for database and edit check specifications testing
Lead and participate in User Acceptance Testing (UAT) for database, edit check specifications.
Oversee data review for overall consistency, data trends and issues and collaborate with CRO on development and implementation on remediation plan(s) and timelines
Oversee vendor data reconciliation (e.g., IVRS, laboratory data, SAE Reconciliation) within the clinical database(s) to include QC of queries/query responses, manual listings, external data reconciliation, metrics, and custom reports as required throughout the study
Track data management activities and issues and ensure follow-up/completion to resolution.
May act as Subject Matter Expert in assigned area(s).
Assist in the creation and review of Data Management SOPs, WIs, and training materials.
Mentor junior level staff and peers on all associated tasks within a study.
Maintain internal data management study documentation to audit ready status
Perform other duties as requested by management
BA/BS, preferably in the scientific/healthcare or related field
5+ years Lead Clinical Data Management experience in Pharmaceutical or Biotech industry
Working knowledge of GCP, FDA, ICH, CDISC, CDASH regulations and guidelines
Detail oriented, ability to multitask with strong prioritization, critical thinking and planning and organizational skills
Ability to communicate data management standards, developments, and challenges in an accurate, concise, and consistent manner to both internal and external stakeholders
Excellent verbal and written communication skills
Proficient working knowledge of EDC platforms, Medidata Rave, Oracle Clinical Inform, Axiom Fusion, various IVRS/IRT solutions, JReview, elluminate, etc.
Experience/Knowledgeable about clinical data management outsourcing with full service global CROs and niche providers
Subject matter expert in EDC-related tools and processes
Demonstrates well-developed instincts and problem-solving skills in all areas of data management
A complete understanding and application of principles, concepts and practices of clinical research procedures and Good Clinical Practice (GCP) is required
Experience in Hematology/Oncology, Neurology, Immunology, Opthalmology and Rare Disease Drug Development preferred and familiarity with gene and/or cell therapy
Experience with all phases of clinical drug development including global regulatory submissions preferred
Strong communication, organizational and interpersonal skills are required
Independent decision-making and analytical skills are required to operationalize and move the clinical trials forward
Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities
Strong understanding of clinical efficacy and safety data, interpretation of tables and listings, and analysis to ensure clinical data integrity
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