Responsibilities:

• You will critically review DM documents for accuracy and acceptability for junior level CDMs to ensure standards for data collection are applied to all studies.
• You will train and supervise clinical data associates.
• You will collaborate with all cross-function team members including Clinical Operations, Biostatistics, Statistical Programmers, etc.
• You will oversee the work of the outsourced CDM vendor for assigned projects.
• You will escalate vendor issues to senior management for resolution.
• You will manage the escalation of study related issues and communicate as appropriate with management.
• You will ensure the activities described in the Data Management Plan (DMP) are executed in accordance with the DMP, including database build and validation, data entry, data transfer, data reconciliation and review, medical coding, data freeze and database lock.
• You may be required to function as lead CDM for multiple clinical trials or oversee the data management team across a collection of studies.
• You will ensure that CDM documentation is filed into the Trial Master File according to SOPs and the study plans; review CDM files for completeness and accuracy.
• You may lead or support inspection activities for CDM and manage any findings thru resolution.
• You will define metrics to measure clinical trial database quality, site and vendor performance and implement those metrics in the clinical trials.
• You will analyze metrics across projects and programs; escalate or inform management and cross functional study team to trends.
• You will identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.
• You will assist with development of therapeutic area standards for Case Report Forms, Edit Checks, and Data Review .
• You will assist in the coordination of the acquisition, development, and implementation of tools to support data management tasks internally; this may include development of specifications, testing plans, and data standards and helping (with the support of Sr. Management) that the entire DM department implements these tools efficiently and effectively.

Requirements:

• You will have a bachelor’s degree or equivalent.
• You will have at least 6 years of direct experience in clinical data management within the biotech or pharmaceutical industry. CRO experience preferred.
• You possess in-depth knowledge and experience in clinical data management processes.
• You are Proficient in multiple EDC platforms, with strong understanding of database design and database concepts and related processes (database builds, updates, locks, etc.).
• You will have working knowledge of CDSIC Standards (CDASH/SDTM) .
• You will have knowledge of international guidelines (ICH-GCP) for the conduct of clinical research projects.
• You will have knowledge of GCPs and regulatory agency guidelines.
• You will have some familiarity with medical terminology.
• You possess great verbal and written communication skills.
• You are a self-starter and are able function well under minimal supervision.
• You have been able to successfully manage multiple projects simultaneously and handle changing priorities, for yourself and DM team across a collection of studies.

• You will critically review DM documents for accuracy and acceptability for junior level CDMs to ensure standards for data collection are applied to all studies.
• You will train and supervise clinical data associates.
• You will collaborate with all cross-function team members including Clinical Operations, Biostatistics, Statistical Programmers, etc.
• You will oversee the work of the outsourced CDM vendor for assigned projects.
• You will escalate vendor issues to senior management for resolution.
• You will manage the escalation of study related issues and communicate as appropriate with management.
• You will ensure the activities described in the Data Management Plan (DMP) are executed in accordance with the DMP, including database build and validation, data entry, data transfer, data reconciliation and review, medical coding, data freeze and database lock.
• You may be required to function as lead CDM for multiple clinical trials or oversee the data management team across a collection of studies.
• You will ensure that CDM documentation is filed into the Trial Master File according to SOPs and the study plans; review CDM files for completeness and accuracy.
• You may lead or support inspection activities for CDM and manage any findings thru resolution.
• You will define metrics to measure clinical trial database quality, site and vendor performance and implement those metrics in the clinical trials.
• You will analyze metrics across projects and programs; escalate or inform management and cross functional study team to trends.
• You will identify and troubleshoot operational problems, issues, obstacles, and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders.
• You will assist with development of therapeutic area standards for Case Report Forms, Edit Checks, and Data Review .
• You will assist in the coordination of the acquisition, development, and implementation of tools to support data management tasks internally; this may include development of specifications, testing plans, and data standards and helping (with the support of Sr. Management) that the entire DM department implements these tools efficiently and effectively