Responsibilities Include

• Assist Data reconciliation of electronic data transfers from vendor to Sponsor.
• Enthusiastic and knowledgeable communication with database (DB) vendors on consistent basis to address Clinical team requests and/or eCRF development activities.
• Provide Clinical Data Management support to the Clinical team and other cross functional departments as needed.
• Develop CRF, electronic and/or paper.
• Participate in the review of Clinical research documents (e.g. Protocols, Case Report Forms).
• Develop clinical trial data specifications, including CRF completion guidelines, user requirements, edit checks and rules, query logic and data validations.
• Participate in UAT of eCRF build and validation documents, including but not limited to edit check document, issue log, and UAT summary report.
• Assist with TLF Development for DSMB/IDMC and endpoint adjudication committees.
• Participate in the preparation and presentation of data, when applicable.
• Ensure data compliance by following the established guidelines of national and international regulatory authorities.
• Assist in the review of routine/interim/final data listings prior to release to other groups or inclusion in regulatory submissions.
• Assist in the gathering of EDC design requirements from stakeholders and to address the needs of sites (e.g., investigator, study coordinator, study monitor) .
• Provide input and support on data and submission standards (e.g., SDTM,ADaM) to project teams to ensure high quality and timely deliverables that meet industry standards and regulatory requirements.
• Support the identification, review, evaluation, and implementation of new technologies related to clinical data and to reduce site burden.
• Participate in data standards process improvement working groups.

Required Qualifications

• Bachelor’s degree in a science related field.
• 8 years data management and drug development in Clinical Data Management function.
• 5 years managing vendor relationships.
• Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
• BLA/NDA/CTD Experience preferred.
• Experience of data management best practices, standards, library development and maintenance.
• Experience with clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.
• Experience of broad drug development process with expertise in the interfaces with the data management function.
• Strategic knowledge of FDA and ICH regulations and industry standards applicable to data capture and data management process.
• Working knowledge of Clinical database applications such as EDC and CTMS.
• Knowledge of general medical coding in the pharmaceutical/biotechnology industry including knowledge of medical dictionaries, coding tools, and coding governance models.
• Ensure adherence to functional budget, and provide updates to manager regarding additional, potential spend or cost savings.
• Knowledge of CDISC standards.
• Experience performing CRF Design activities in a clinical research environment.
• Outstanding verbal, written , organizational, interpersonal, and team skills.
• Create and implement solutionsbased on direct experience.

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