Job Description

• Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
• We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description

Responsibilities:

• Act as Lead Data Manager, overseeing all deliverables of activities outsourced to DM CRO for multiple studies.
• Interact and manage relationships with other functional areas to ensure high quality data management activities.
• Oversight of data collection tools (EDC, DTAs, EDC integrations) and essential documents (DMP, UAT Documents, data edit specifications, annotated case books and data entry guidelines).
• Participate in User Acceptance Testing Activities for the applicable Data Collection Tools.
• Perform Quality Control for the data completeness and accuracy.
• Participate in and support data cleaning, query generation and resolution and review of medical coding as needed.
• Responsible for adhering to the Data Management timelines and budget.
• Provide technical expertise to help in the use of technologies for Data Management and the clinical study team.
• Contribute to the development of lessons learned and best practices as well as help develop SOPs and internal working procedures and process improvement initiatives.
• Contribute to the establishment of systems and tools to help ensure clinical data security and integrity.
• Contribute to the process to identify, evaluate and select external business partners and technology vendors.

Requirements:

• 8+ years' experience in clinical data management in biotechnology or pharmaceutical industry, with outsourced CRO oversight experience.
• Must have advanced knowledge of Data Management processes and systems
• Oncology experience required.
• Solid understanding of CDISC standards required.
• Data Visualization Tool experience preferred.
• Experience using standardized medical terminology, including but limited too MedDRA and WHO Drug.
• Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a study team environment.

Additional Information

All your information will be kept confidential according to EEO guidelines.

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