Clinical Data Manager

Company : Katalyst Healthcares & Life Sciences

Country: United States

Location : Boston, Massachusetts

Post: Sun, 28 May 2023 06:39:27 GMT

Expires: Sun, 25 Jun 2023 23:59:59 GMT

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—————————— Job Description ——————————

Responsibilities:

Manage clinical trial data or data management projects under aggressive timelines, and in a high quality, professional manner, all while adhering to SOPs and work guidelines.

Oversee Clinical Data Management vendors to ensure vendors deliver quality work in a timely manner.

Create, review, and approve data management plans (DMP) and all data management documentation, ensuring all study documents to be filed in the eTMF are ready for regulatory inspection.

Lead regular data review meetings in a cross-functional team environment.

Work with safety and PV to develop study specific Serious Adverse Event (SAE) reconciliation guidelines in order to reconcile SAEs.

Review and provide feedback on study protocols and cross functional study documents e.g. Clinical Monitoring Plans, Statistical Analysis Plans, etc.

Develop and review clinical data management functional processes, SOPs, and working instructions.

Requirements:

Bachelor or master’s degree in Science, Health Care or related field

Minimum 5 years of clinical data management experience within Biopharma/CRO environment.

Oncology/Immuno-Oncology experience is preferred.

Proficient working knowledge of any of the following strongly desired: SAS, Review or other Visualization Tools, Data standards (CDASH and CDISC SDTM)

Prior working experience in Rave or InForm EDC, solid technical skills and fast learning ability on new technologies and applications.

Overall understanding of ICH, GCP and other applicable regulatory guidelines as they pertain to clinical data management.