SR. CLINICAL DATA MANAGER

StatMinds LLC.; King of Prussia (PA); On-site; USD 116,000 - 142,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vacation and sick Days

Relocation Allowance

Per Diem Option

Visa Sponsorship

Job summary

StatMinds LLC is seeking a lead data manager to create DM plans, review coding conventions, and supervise UAT on clinical data bases. The role includes leading programming for analysis datasets, TLFs, data validation, and study documentation maintenance.

The candidate will execute SAE and data reconciliation across several clinical trials and ensure QC/UAT of EDC tools, with travel to various locations in the US as needed.

Qualifications

• Master’s degree in Health Care Informatics or Health Administration with 1 year of related experience.
• Experience documenting DM documents in Veeva Vault eTMF and reviewing ALS, eCRF specifications, and aCRFs.

Responsibilities

• Create a data management plan (DMP), edit check specs, data transfer agreements (DTS), and a reconciliation plan.
• Perform UAT on Clinical Data Base and provide feedback on programmed listings and edit checks.
• Lead programming for analysis datasets, Tables, Listings and Figures, and study documentation maintenance.
• Execute SAE and data reconciliation for multiple clinical trials.
• Ensure QC and UAT of EDC tools and modules, including database testing and data exporting.

Skills

SAE

UAT

Veeva Vault

EDC tools

Education

Master’s degree in Health Care Informatics or Health Administration

Tools

Veeva Vault

EDC tools

Job description

DUTIES: Create a data management plan (DMP), edit check specifications, data transfer agreements (DTS), an SAE reconciliation plan, and a document with coding conventions & specifications; Conduct User Acceptance Testing (UAT) on Clinical Data Base & provide feedback to the team on programmed listing and edit checks; Lead programmer in the creation of analysis datasets, TLFs (Tables, Listings, and Figures), data and report validation, and study documentation maintenance; Execute SAE and data reconciliation for a number of clinical trials; Experience documenting DM documents in Veeva Vault eTMF, reviewing ALS, eCRF specifications, & aCRF’s while performing EDC initial build and migrations; Ensure that QC & UAT of EDC tools & modules are completed properly, including database testing, data exporting, and programming. Skills- SAE, UAT, Veeva Vault & EDC tools. Must be willing to travel and/or relocate to work in unanticipated locations throughout the US.

REQUIREMENTS: Master’s degree in Health Care Informatics, Health Administration with 1 year of experience a job title with similar duties and skills.

SALARY: $128,773.00

HOURS: 40 hours/week, Mon-Fri, 9:00am – 5:00pm

JOB LOCATION: Statminds, LLC, 501 Allendale Rd, Suite 202, King of Prussia, PA 19406

Salary & Employee Benefits

• Medical Insurance
• Dental Insurance
• Vacation and sick Days
• Relocation Allowance
• We offer Per Diem Option
• Visa Sponsorship

Hourly W2 Consultants

• Medical Insurance
• Dental Insurance
• Relocation Allowance
• We offer Per Diem Option

Corporation

For some assignments, if a
consultant owns a corporation with a
federal tax ID number, we can pay
them as a corporation.