JOB SUMMARY: Perform data management tasks from study start up through database lock, including database set-up and data validation as per the requirements in the clinical protocols and ensure timely delivery of high-quality consistent data. Lead portions of a project with no supervision or a full project with minimal supervision. JOB RESPONSIBILITIES: • Adherence to SOPs and maintaining audit-ready documentation. • Coordinate data management activities, ensuring high quality, respecting project timelines and adherence to the budget for a full project or dedicated part of a project. • Attend relevant project meetings and work closely with other internal and external leads. • Liaise with client/partners for clarification on any clinical and / or technical decisions and propose most efficient solutions. • Identify risks to project deliverables and timelines and notify the appropriate personnel. • If acting as Lead Clinical Data Manager, create DM timelines for database set-up. • Lead and participate in the design of Clinical Electronic Data Capture (EDC) components including mock CRF, casebook, edit checks. • Coordinate and create data management documentation including Data Management Plan, Data Validations Specifications, eCRF Completion Guidelines, Data Collection System Configuration, Data Transfer Agreement. • Coordinate and perform User Acceptance Testing. • Train EDC users. • Manage EDC users’ access and assist with resolving issues. • If acting as Lead Clinical Data Manager, coordinate all conduct Data Management tasks. • Lead and participate in data cleaning activities including SAE and external data reconciliation. • Provide input to protocol and assess database impacts based on protocol changes during study lifecycle; prepare and execute change request forms. • Lead and participate in Database Lock activities, including timelines creation, QC coordination and Data Management Report creation. • Assist with evaluating data management needs and propose appropriate, innovative, and efficient data management solutions. • Participate in writing departmental procedures and guidelines. • Train and mentor less experienced staff. QUALIFICATIONS: Education: Bachelor’s degree in Life Sciences, Computer Science or related discipline. Experience: A minimum of five years of progressive experience in Clinical Data Management or Clinical Research Skills: • Proficient in at least one of the prevalent EDC tools (Medidata Rave, Merative Zelta, Medrio, VieDoc, Oracle InForm). • Strong knowledge of the pharmaceutical industry including understanding of clinical drug development process and associated documents (SOPs/Guidelines/Work Instructions). • Knowledge of ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11. • Good knowledge of data, databases, and data procedures. • Working knowledge of CDISC standards for data management. • Proficient with Microsoft Office Suite (Excel, Word, PowerPoint). • Good verbal and written communication. • Flexibility, proactivity, and ability to work independently and in a team environment. • Detail-oriented with analytical mind-set. • Good problem-solving skills. • Project management and negotiation skills. Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law.