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.

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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical data managementelectronic data capture (EDC)database managementdata reviewcoding of adverse eventsdata management best practicesdata management documentationquery generationedit checksdata analysis

Soft Skills

communication skillsorganizational skillsinterpersonal skillsmentoringguidancecollaborationtraininganalytical insightinfluenceprocess improvement