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Fore Biotherapeutics · 1 month ago

Clinical Data Manager

Philadelphia, PA, US

Full-time

Onsite

Mid Level

3+ years exp

Fore Biotherapeutics is seeking a Clinical Data Manager (CDM) to ensure the integrity and quality of clinical trial data. The CDM will collaborate with cross-functional teams on data management activities, executing end-to-end data management processes in compliance with industry standards.

BiotechnologyHealth CareHealth DiagnosticsMedicalOncology

Responsibilities

Serve as a Data Manager across multiple study projects and have contact with Clinical Study Teams and Data Management counterparts at Contract Resource Organizations

Liaise directly with internal team and external vendors to coordinate aspects of data management activities

Interact with the CRO and/or clinical sites for DM activities and deliverables in conjunction with the study team

Perform data review in EDC and patient profiles; issue queries as needed

Collaborate with cross-functional teams to ensure integrated cross-functional oversight of data integrity and quality

Ability to create customized data listings (via Excel or other tools) and trackers as needed to help with data-related deliverables

Communicates project status and vendor performance in relation to both quality and timelines. Contributes to risk mitigation or action plans where appropriate

Participates in the review of protocols and other study related documents as required

Participates in User Acceptance Testing (UAT) and documentation for assigned studies databases

Identify and implement data review initiatives/key quality indicators helping to ensure continuous oversight of data

Ensure compliance with industry quality standards, regulations, guidelines and procedures

Other duties as assigned

Qualification

Clinical data managementICH/GCP guidelinesMicrosoft ExcelOncology trial experienceEDCMedical codingHighly motivatedData visualization toolsBasic programming SASBasic programming RBasic programming PythonTime managementCommunication skillsCreativityFlexibility

Required

Minimum 3 years of clinical data management experience in Pharmaceutical/Biotechnology industry

Knowledge of ICH/GCP guidelines, 21 CFR Part 11 and CDISC standards regarding drug development phases, clinical research and data management standards

Familiarity with data collection practices for laboratory results and reference ranges, clinical diagnostic procedures, and disease history and processes

Strong time management and organizational skills

Strong written and verbal communications skills

Highly motivated individual with the flexibility and creativity to excel in and contribute to a rapidly growing company

Proficiency in Microsoft Office Applications, especially Excel