DOCS Sr. Clinical Data Manager in Austin, Texas
Sr. Clinical Data Manager
Ref #: 22763
Employment type: Permanent - Full-Time
Clinical Data Manager
DOCS is currently seeking an experienced individual for a home-based Clinical Data Manager position. This position requires previous experience in a pharma/CRO setting and experience in data management.
• Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements, etc.
• Provides oversight and accountability for more than one low to moderate complexity trial or one high complexity trial for data management activities. May be a member of more than one project of low to moderate complexity or member of one project of high complexity.
• Takes a leadership role with the CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s).
• With the trial customer, CRO and other functional partners: – Gathers content and integration requirements for eCRF and other data collection tools. – Establishes conventions and quality expectations for clinical data. – Establishes expectations for dataset content and structure. – Set timelines and follow‐up regularly to ensure delivery of all Data Management milestones.
• Performs trial level oversight controls as described in the oversight plan, QC process and work instructions with minimal DML direction.
• Reviews clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.
• Ensures real‐time inspection readiness of all Data Management deliverables for the trial; Participate in Regulatory Agency and internal audits as necessary.
• Plans and tracks content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival. Ensures deliverables are on time.
• Takes a leadership role with the assigned clinical working group(s) to ensure that Data Management and TA trial needs and deliverables are met.
• Identifies and communicates lessons learned, best practices and frequently asked questions at the trial level.
• Presents and trains at investigator and monitor meetings
• Bachelor’s degree or equivalent, in Health or Science discipline with experience in clinical research.
• Data Management experience.
• Experience working on a clinical trial.
• Experience working in highly diverse teams within clinical research; cross‐functional, global, multi‐regional.
• Project management skills.
• Vendor management skills.
• Advanced Microsoft Office skills including the ability to manipulate and analyze data.
• Highly organized with excellent written and verbal communication.
• Ability to interpret clinical trial data and present trends to clinical trial team on data.
DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.
DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.
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