Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
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 J&J 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 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.