Clinical Data Manager – California or New Jersey
Clinical Data Manager
Integrium is a privately owned, full-service CRO focused within the therapeutic areas of Cardiovascular, Metabolic, Renal, Inflammatory, Dermatology, Wound Healing, Regenerative, and Orphan Diseases. Since our founding in 1998, Integrium has been a firm based on therapeutic focus and excellence. Today, we have global operations, including our offices in North America and formal alliances with partner CROs regionally and in Europe, Australia, and India.
We are a progressive employer offering competitive benefits and growth opportunities in an atmosphere that strives to foster the achievement of professional and personal goals. We are currently seeking approachable, accountable, capable and committed professionals to join our growing team. Are you one of those professionals? If so, we want to hear from you!
The Clinical Data Manager is responsible for and performs the day to day tasks associated with reviewing and cleaning a clinical database. The Clinical Data Manager will review electronic discrepancies, issue and resolve queries. Update the database based on query responses, as well as Self Evident Corrections and perform manual checks on CRF (Case Report Form) pages. Also, they are responsible for and perform listing review and Quality Control activities, the development and testing of entry screens and edit checks, development of CRFs and CRF Guidelines and Data Clarification Form (DCF) tracking and daily reports, setting up and closing clinical databases, as well as developing and maintaining study documentation. This position also assists in process improvement activities.
ESSENTIAL JOB FUNCTIONS:
- Develop and test data entry screens and edit checks, CRF tracking, DCF tracking, and other day-to-day reports and tools.
- Maintain project specific data management documentation.
- Attend all internal and external meetings (as needed) involving assigned projects.
- Responsible for the data clarification process by producing automated and manual queries, tracking outstanding DCFs and reviewing the correction and completion of returned DCFs.
- Responsible for all database closure activities on assigned projects.
- Review data listings for any further DCFs. In addition, review data listings to ensure data quality.
- Function as the primary contact for sites or other staff members if there are questions regarding outstanding DCFs.
- Responsible for the specifications for setting up the clinical database for assigned projects.
- Develop and maintain Data Management study documentation.
- Oversee and perform day-to-day Data Management related functions in conjunction with the project teams.
- Assist in the overall Quality Control processes across all studies.
- Assist in the development of Standard Operating Procedures and Work Instructions.
- Provide input to department/Company improvement activities.
- Strict adherence to company and/or Sponsor SOPs and Corporate Policies.
- Represent Integrium’s service commitment of integrity, integration, initiative and intelligence on a consistent basis with all interactions encountered.
EDUCATION AND EXPERIENCE REQUIRED:
- Bachelor's degree or equivalent experience in the health science field.
- Requires at least 2 years of experience in a CRO, pharmaceutical or biotechnology industry data management environment (transferable skills).
ADDITIONAL SKILLS AND COMPETENCIES:
- Ability to work on multiple tasks and projects.
- Ability to provide technical expertise.
- Ability to work in a multi-disciplinary team setting.
- Computer proficient in a Microsoft Windows environment.
- Good organizational skills.
- Strong leadership skills.
- Strong interpersonal skills.
- Excellent problem-solving skills.
- Strong attention to detail and accuracy.
- Strong commitment to quality.
- Must be customer oriented and flexible.
- Must be able to work independently and in a team environment, and working well with others in high pressure situations.
- Excellent ability to communicate effectively and clearly, both orally and in writing.
- Exceptional organizational and time management skills and ability to multi-task projects for timely completion.
Equal Opportunity/Affirmative Action Employer
Integrium, LLC is an equal opportunity employer and promotes a work environment where diversity is embraced.