JOB SUMMARY: Coordinate and 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 all portions of a project/and or multiple projects with minimal or no supervision. JOB RESPONSIBILITIES: • Adherence to SOPs and maintaining audit-ready documentation. • Coordinate and oversee activities of all DM staff assigned to the project, ensuring high quality, respecting project timelines and adherence to the budget. • 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, develop and implement the mitigations for these risks. • 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. • 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. • Contribute to departmental procedures and guidelines. • Critically evaluate data management needs and propose appropriate, innovative, and efficient data management solutions. • Train and mentor less experienced staff. • Represent Cytel at project, proposal, or industry meetings. • May participate in the recruitment process. • Contribute to budget evaluation for proposal writing purpose and be Data Management representative during bid-defense, as needed. • Support senior team members and/ or be the data management representative during audits. Cytel Confidential: This is a controlled document and shall not be changed, saved, copied or reproduced by any unauthorized person. • May act as a line manager, contribute to the development of a strong team of data managers, by functionally managing and guiding the data managers with respect to data management strategy, deliverables, processes, and professional development. QUALIFICATIONS: Education: Bachelor’s degree in Life Sciences, Computer Science or related discipline. Experience: A minimum of eight years of progressive hands-on experience in Clinical Data Management or Clinical Research. Skills: • Proficiency in at least one of the prevalent EDC tools (Medidata Rave, Merative Zelta, Medrio, VieDoc, Oracle InForm). • Advanced 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. • Strong knowledge of data, databases and data procedures. • Working knowledge of CDISC standards for data management. • Proficient with Microsoft Office Suite (Excel, Word, PowerPoint). • Excellent verbal and written communication. • Flexibility, proactivity, and ability to work independently and in a team environment. • Detail-oriented with analytical mind-set. • Excellent problem-solving skills. • Project management and negotiation skills. • Strong leadership and mentoring 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.