Data Manager is responsible for managing data cleaning tasks, medical coding and vendor data reconciliation. Data Manager will maintain these tasks across multiple studies and EDC platforms.
DUTIES AND RESPONSIBILITIES:
- Be responsible for participating in all data management activities from initiation of protocol through database lock Data Cleaning activities
- Have the ability to support a number of moderate complexity / complex trials with minimal supervision
- Reviews Medical Coding (If needed), Serious Adverse Event and Vendor Data Reconciliation
- Manage the entry and review of Local/Central Lab ranges
- May provide input for and may create or draft CRF design, edit check specification and DM reports and listings.
- Perform validation of EDC Systems and associated DM reports or listings
- Create and maintain DM documentation as directed by the Lead Data Manager or Project Data Manager including: EDC Specifications, Data Management Plan, CRF Completion guidelines, Vendor reconciliation guidelines, and report specifications.
- Attend internal/external teleconferences as needed
- Create and Review Study metric reports for internal/external project teams
- Discuss roadblocks for getting processes done in a timely manner and offer possible solutions
- Provide the Lead DM or Project Data Manager with status updates on tasks that are assigned
- Escalates significant issues promptly to the study team
- Ensure that key project documentation and project files are maintained and up to date Understand at an advanced level and adhere to quality and regulatory standards (GCP, 21 CFR part11 and customer procedures) and MedSource SOPs and processes
MINIMUM JOB REQUIREMENTS / QUALIFICATIONS:
- College diploma or university degree, or equivalent knowledge and experience, and
- Clinical data management experience in pharmaceutical industry and/or contract research organization
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
- Must be a team player with ability to work well with and interact with other study team members and answer questions related to specific data collection concerns
- Ability to create and maintain DM study documents (CRF guidelines, DMP, edit checks, etc.)
- Good knowledge of multiple EDC systems
- Organized and thorough with attention to details
- Effective Interpersonal skills and good communications skills, verbal, written and listening
- Willingness to learn new things
- Ability to accept constructive criticism
- Ability to adhere to detailed instructions
- Effective logical thinking ability in regards to Problem-solving skills
- Proficiency in computer applications: Windows, Excel, Word, Outlook etc.
- Ability to work independently
CONDITIONS OF EMPLOYMENT:
- Verification of educational requirements, employment history, professional references, and certifications/training.
WORKING CONDITIONS AND PHYSICAL EFFORT:
- Work is normally performed in a typical interior/office work environment
- 5% of Travel Required
We are committed to diversity in the workplace and are an equal opportunity employer.