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Outsmart Your Disease™
Clinical Data Manager
Location
United States
Posted
98 days ago
Salary
$103.5K - $115K / year
Seniority
Senior
Job Description
Clinical Data Manager
ImmunityBio, Inc.
• Create and/or review study-specific electronic or paper Case Report Forms (CRFs) using prior knowledge, protocol-specific information, and departmental standards. • Work efficiently to incorporate core clinical team input and produce CRFs in a timely manner. • Configure, migrate, and test electronic data capture (EDC) databases based on internal procedures, study requirements, and system best practices. • Serve as a database manager for the study-specific clinical team, including the compilation of edit checks. • Develop database requirements for use by EDC vendors. • Serve as a study database manager and work with vendors to obtain deliverables in a timely manner. • Create and/or review study-specific data management and database documentation, which may include: Data Management Plan CRF Completion Guidelines Coding Guidelines Annotated CRFs Edit Check Specifications. • Attend study-specific team meetings and produce status reports and requested metrics, which may include query information or data trends. • Perform data review and query generation/closure. • Perform coding of verbatim terms such as adverse events and concomitant medications. • Collaborate with medical scientists for coding, consistency, review, and approval. • Incorporating coding files into the clinical database. • Participate in the development of new processes or revision of existing processes. • Train internal colleagues in clinical data management in either informal or formal settings as needed. • Train Investigators and/or Study Coordinators at Investigator Meeting on the CRFs, the EDC system, and the CRF completion guidelines as needed. • Provide data management expertise and support to the clinical teams using data management best practices. • Provide analytical insight into data management strategies and advise the internal team with tactical strategies accordingly. • As necessary, provide work direction, guidance, mentoring, influence, and support to junior staff. • Train junior staff in more complex clinical data management processes. • Adhere to Standard Operating Procedures (SOPs), process improvements, and standardization of templates. • Perform ad-hoc and cross-functional projects assigned to support business needs and provide developmental opportunities.
Job Requirements
- Bachelor’s Degree in a science-related field with 4+ years of experience; or High school diploma with 8+ year of relevant experience.
- 4+ years of clinical data management experience required.
- Experience working with EDC clinical databases required.
- Veeva Vault CDMS and TrialMaster experience preferred.
- MedDRA and WHO Drug coding experience preferred.
- Working knowledge of clinical research, Good Clinical Practices, and regulatory requirements.
- Knowledge of CDISC/STDM standards.
- Excellent English verbal and written communication skills; good organizational and interpersonal skills.
Benefits
- Medical, Dental and Vision Plan Options
- Health and Financial Wellness Programs
- Employer Assistance Program (EAP)
- Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
- Healthcare and Dependent Care Flexible Spending Accounts
- 401(k) Retirement Plan with Company Match
- 529 Education Savings Program
- Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
- Paid Time Off (PTO) includes: 11 Holidays
- Exempt Employees are eligible for Unlimited PTO
- Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day
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