Clinical Data Manager
Integrium is a full-service (CRO) Firm focused on drug and device development within the therapeutic areas of Cardiovascular, Metabolic, Renal, Inflammatory, Dermatology, Wound Healing, Regenerative, and Orphan Diseases.
Integrium is looking to hire a Clinical Data Manager in our Cedar Knolls, NJ office. The Clinical Data Manager is responsible for and will perform 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. In addition, he/she will update the database based on query responses, as well as Self Evident Corrections and perform manual checks on CRF (Case Report Form) pages. Furthermore, the Data Manager is responsible for and will 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.
In order to be considered for this position, all canididates must have the following education/work experience:
- Bachelor's degree or equivalent experience in the health science field.
- MINIMUM 3 years’ experience working with various EDC systems.
- MINIMUM 3 years’ experience working in a CRO, pharmaceutical or biotechnology industry data management environment.
- MUST have experience creating a data management plan.
- Completed a database lock
- Be familiar with 3rd party vendor reconciliation and UAT Testing.
- Understand CRF completion guidelines.
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.
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.
Integrium also provides a benefits package that includes:
- Vacation Pay, Personal Time and Sick Time
- Health Insurance (PPO, HSA)
- Dental and Vision plan
- Prescription Drug plan
- Life Insurance
- Short-term Disability
- Long-term Disability
- 401(k) Plan
Equal Opportunity/Affirmative Action Employer
Integrium, LLC strongly supports and values the uniqueness of all individuals and promotes a work environment where diversity is embraced.