Principal / Senior Clinical Data Manager (Metadata Rave / IBM

Join us in playing an important part in helping our clients drive healthcare forward and ultimately improve human health outcomes!

Cytel provides unrivalled biostatistics and operations research to improve drug development success rates, crucial for human welfare. Focused on using innovative applications of statistical science and adaptive clinical trial design, Cytel is at the cutting edge of technology and human ingenuity, driving healthcare forward.

We are hiring a remote Principal / Senior Clinical Data Manager to join our growing Project-Based Services (PBS) division.

Your Impact

As a seasoned Clinical Data Manager, you will lead all portions of a project, which may include multiple projects simultaneously, from study start-up through database lock, working independently and committing to project deadlines and budgets. Ideally, you will have experience in Metadata Rave design or IBM Clinical Development EDC, with experience supporting Oncology studies. You will report to the Executive Director, Data Management.

Additionally, you will contribute by:

critically evaluating data management needs

proposing appropriate, innovative and efficient data management solutions

database design, development, implementation, testing and maintenance

ensuring consistency with project and industry standards

overseeing creation and maintenance of all relevant documentation

timely delivery of high-quality consistent data

liaise with clients/partners for clarification on any clinical and/or technical decisions and propose the most efficient solutions

attending/presenting at relevant project meetings and works closely with other internal and external leads

identifying risks to project deliverables and timelines and proposing potential solutions to the appropriate personnel

performing and supporting data activities, processes and metrics

executing secure and effective data procedures in collaboration with data management team members

understanding and complying with core operating procedures and working instructions

ensuring the completeness and validity of data entered into the database

overseeing process of training EDC users

training and mentors junior Clinical Data Manager staff. May include management of staff.

participating in the proposal process

contributing to departmental procedures, guidelines and trainings

identifying process gaps and potential solutions

representing Cytel at project, proposal or industry meetings

What we’re looking for:

Bachelor’s degree in life or computer sciences or other related discipline

10 years of progressive hands on experience in Clinical Data Management or Clinical Research

Proficiency in Metadata Rave, with experience in design.

Knowledge of clinical data, relational databases and data procedures

Knowledge of SOPs/Guidelines/Work Instructions/System Life Cycle methodologies

Knowledge of ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11

Proficiency in other CDM tools (IBM Clinical Development, Medio, VieDoc, Oracle InForm)

Knowledge of CDISC standards for data management

Experience in IBM Clinical Development EDC strongly desired

Experience supporting Oncology studies a plus

Analytical thinking and troubleshooting skills

Ability to work independently, and commit to project deadlines & budgets

Ability to critically evaluate data management needs

Organizational, data coordination, handling or research project understanding

Excellent verbal and written communication

Basic S Plus or SAS programming is a plus

Proficiency with Microsoft office tools – Excel, Word, etc.

Working knowledge of medical coding utilizing standard medical dictionaries

Experience working in a CRO environment strongly preferred

What’s in it for you:

You will have the opportunity to play an integral role helping our clients and the industry shape the future of drug development

You will be part of an exciting new chapter in Cytec’s history with high growth and opportunities to progress in Senior and Leadership positions within the company

Work in an environment designed for an entrepreneurial minded person with a lot of energy, ideas and courage for their implementation

Work with and leverage the best and brightest minds in the industry

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.