Cytel provides unrivaled biostatistics and operations research knowledge to our customers in the life sciences industries in the form of both software and services. At Cytel, we work hard to create successful careers with significant professional growth for our employees, as a result of which they work hard to make Cytel successful. Cytel is a place where talent, experience and integrity come together to advance the state of clinical development.

JOB SUMMARY:

The Senior Clinical Data Manager performs 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 ensuring timely delivery of high-quality consistent data. He/She leads portions of a project with no supervision or a full project with minimal supervision.

JOB RESPONSIBILITIES:

• 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 notifies the appropriate personnel.
• Create data management documentation.
• Lead and participate to the design of Clinical Electronic Data Capture (EDC) components.
• Coordinate and perform User Acceptance Test.
• Train EDC users.
• Lead and participate in data cleaning activities.
• Provide input to protocol and assess database impacts based on protocol changes during study lifecycle; prepare and execute change request forms.
• Manage EDC users’ access and assist with resolving issues.
• Participate and coordinate all conduct Data Management tasks.
• Participate in final data QC prior to database lock.
• Assist with evaluating data management needs and propose appropriate, innovative and efficient data management solutions.
• Participate to departmental procedures and guidelines writing

QUALIFICATIONS:

Education: Bachelor degree in Life Sciences, Computer Science or related discipline

Experience: A minimum of 5 years of progressive experience in Clinical Data Management or Clinical Research

Skills:

• Experienced with using EDC tools
• Builder certification for Medidata and or IBM Clinical Development is a plus
• Oncology experience is a plus
• 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
• Good Knowledge of data, databases and data procedures
• 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
• Working knowledge of CDISC standards for data management
• Proficient with Microsoft Office Suite (Excel, Word, PowerPoint)

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.

Cytel does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Cytel’s human resources department to obtain prior written authorization before referring any candidates to Cytel. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and Cytel. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of Cytel. Cytel shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies.