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Senior Clinical Data Manager

Katalyst Healthcares & Life Sciences • Parker, CO, United States • $200k - $250k / year • 3w ago

Responsibilities:

Lead clinical data management activities for biopharma partnerships, Foresight-sponsored studies (prospective and retrospective), investigator-initiated trials, and other analytical needs as required.
Develop and maintain data management documentation, including data management plans, relevant portions of study protocols, case report forms (CRF), and CRF completion guidelines.
Develop data transfer file requirements and templates for exchange of clinical data, MRD testing data, and biospecimen manifests.
Perform data cleaning activities, including discrepancy management and query resolution for prospective data collection and dataset for retrospective studies.
Data aggregation and internal database development for storage of laboratory and testing data related to clinical trial conduct and evaluation of MRD test performance. Generate and review clinical study dashboards and data summaries for use in tracking study progress, centralized data monitoring, and study reports.
Design case report forms (CRFs), electronic data capture (EDC), and electronic patient-reported outcomes (ePRO) systems for data collection.
Conduct data validation checks and implement quality control measures to ensure accuracy and completeness.
Develop and execute standard operating procedures (SOPs) for approval, data entry screen design and testing, validation check testing and approval.
Collaborate with study team members to resolve data-related issues and discrepancies.
Ensure compliance with guidelines, Good Clinical Practice (GCP), CDISC standards and other relevant regulations.
Contribute to the development and validation of data management software tools.

Requirements:

3-5 years of experience in clinical data management or a similar role in the pharmaceutical or clinical research industry.
Strong understanding of clinical trial processes, data management principles and regulatory guidelines.
Proficiency in electronic data capture (EDC) systems and clinical data management software.
Familiarity with relevant regulations and guidelines, like GCP and CDISC standards.
Knowledge of industry-standard data analysis and reporting software, such as SAS, SQL and/or Oracle Clinical.
Excellent attention to detail with problem-solving and analytical skills.
Strong organizational and time management abilities. Experience in molecular diagnostics and oncology.
Certification in clinical data management (like CCDM).
Knowledge of CDISC standards and data interchange formats (e.g., SDTM, ADaM).
Familiarity with clinical trial design and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP).

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