Senior Clinical Data Manager Cytel Software
THIS JOB HAS EXPIRED Company Profile
Cytel Inc. is a leading provider of clinical research services and trial design and analysis software/services primarily for the biopharmaceutical, medical device, academic and government researchers. All 25 leading global biopharma companies and over one thousand specialty developers, leading university and government-sponsored research centers use our technology in their clinical studies. Pioneers of the supporting statistical methods, every adaptive trial we've designed has been accepted by regulators. We're also increasing known for our cutting-edge clinical data handling techniques and management strategies.
Cytel is an equal opportunity employer with a work environment that supports both training and mentoring within the company.
We are currently searching for a highly motivated, capable and experienced Senior Clinical Data Manager (SCDM). In summary, the SCDM is responsible for the creation, updating, maintenance and validation of clinical study databases. The SCDM is a key member of the clinical project team and will prioritize work in line with departmental and organizational management decisions.
Core responsibilities are to assist in database set and development, data review and cleaning, and auditing of the clinical data in compliance with standard operating procedures and regulatory agency guidance.
? Serve as the clinical data management subject expert on multidisciplinary clinical project teams providing specific expertise on timeline development and identification of data management deliverables.
? Serve as the Lead Clinical Data Manager on project coordinating within data management and across departments.
? Interface with customers throughout the lifecycle of the project.
? Design, author, develop and program as appropriate Case Report Forms, Databases, Data Management Plans, Edit Checks, Data Queries and other study specific tools and documents pertinent to the management of a clinical trial.
? Review and approve eCRF design, data review and database design guidelines according to Standard Operating Procedures and protocol specific requirements.
? Assist in the development and implementation of the design and programming of clinical databases and data cleaning procedures.
? Create data entry instructions and CRF Completion Guidelines.
? Assist in data receipt and processing, which may include printing CRF/DCF received electronically, hard copy CRF/DCFs, data entry and data reconciliation.
? Review, analyze, and validate clinical trial data throughout the study lifecycle to ensure data consistency, integrity and accuracy based on project specific guidelines.
? Query data inconsistencies and revise case report forms in compliance with standard operating procedures, protocol requirements and regulatory agency guidelines.
? Generate and review reports and listings as required to maintain data integrity and reporting.
? Execute quality control activities such as preparing and carrying out internal database review, performing visual QC on data transfers and interim data reporting.
? Assist in cleaning data for study close out and perform database lock procedures.
? Execute a variety of administrative tasks including but not limited to filing, printing, formatting deliverables, creating binders and other study admin tasks as warranted.
? Familiarity with and demonstrated knowledge of personal computers and database management software and leading EDC systems.
? Excellent communication skills and capability of working with individuals across multiple disciplines in an international environment.
? Experience with EDC, ePRO, including implementation of such systems.
? Experience of working in a global environment, knows how to manage across cultures.
? Strong organizational skills and ability to prioritize work for self and others to ensure timelines are met.
? Knowledge of medical terminology and the drug approval process.
? Demonstrated interpersonal and project management skills.
? Very good knowledge of international regulations for clinical trials (e.g. ICH-GCP) and familiar with CDASH/CDISC standards.
? Use of Microsoft Office Suite (Word, Excel).
? Undergraduate degree in science, or health-related field from an accredited institution, or equivalent work experience required
? Experience in the pharmaceutical, biotechnology or CRO industry is preferred
Compensation & Benefits
Cytel offers a competitive salary-based package, bonus, comprehensive medical and dental benefits, plus a contributing 401K plan.
||Waltham, MA |
THIS JOB HAS EXPIRED