Sr. Clinical Data Manager
Responsibilities: The Senior Clinical Data Manager provides oversight and accountability and/or executes data management activities and/or performs scientific data review for multiple low, moderate and high complexity trials
The Senior Clinical Data Manager makes recommendations and decisions that have an impact on processes, timing, and structure for trials and assignments with minimal direction from manager or Data Management Leader (DML)
This position also makes recommendations for processes, timing, structure, and resources at a program level
Work is received in broad terms, reviewed during major deliverables, and the amount of instruction is limited
Work is reviewed with the Data Management Leaders, or the immediate manager as needed
Take a leadership role with external suppliers, trial customers and other internal/external partners to establish, align and confirm data management and/or clinical data management expectations to the business for assigned trial(s) to include but not limited to:
Gather and/or review content and integration requirements for eCRF and other data collection tools
Establish conventions and quality expectations for clinical data
Establish expectations for dataset content and structure
Set timelines and follow-up regularly to monitor delivery of all data management milestones
Ensure accurate review of related clinical data management documents as well as compliance with regulatory guidelines and documentation requirements
Ensure real-time inspection readiness of all DM deliverables for the trial; participate in Regulatory Agency and Pharmaceutical internal audits as necessary
Lead the planning and tracking of content, format, quality, and timing of applicable data management deliverables
Ensure deliverables are on time
Take a leadership role to obtain and share best practices with internal partners
Identify and communicate lessons learned, best practices and frequently asked questions at the trial level
Create key functional plans (e.g. study Integrated Review Plan) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format, and consistency
Identify and participate in process, system, and tool improvement initiatives
Lead others in implementing process, system, and tool improvement initiatives
Perform (complex) scientific study data review and management of CDM, Study Responsible Scientist (SRS, and Study Responsible Physician related queries in EDC system
Involvement in other clinical data review activities (e.g., Coding, SAE reconciliation) is possible
Take a leadership role in collaborating with the SRS/SRP to ensure that DM and Therapeutic Area trial needs and deliverables are achieved.
Requirements: Bachelor's or Masters degree required
4 years' experience in Pharmaceutical, CRO, Biotech, or Health related field or industry
Experience in clinical drug development within the pharmaceutical or related industry
Experience in clinical data review and knowledge of medical terminology
Experience working with cross functional stakeholders and teams
Strong written and verbal communication skills
Team leadership experience (direct line management not required)
Strong clinical data management experience and/or knowledge of scientific concepts presented in clinical trial protocols
In-depth knowledge of current clinical drug development processes
Knowledge of applicable international guidelines regarding data management of clinical trials
Knowledge or technology platforms and systems to capture and process data as well as understanding of data privacy rules in relation to clinical data exchange
Knowledge of current industry standard (i.e., CDISC, SDTM, CDASH, etc.)
In-depth knowledge of project management and techniques