Description:

Develop and maintain study-specific documentation, including Data Management Plans, eCRF specifications, CRF Completion Guidelines, Data Validation Guidelines, add Data Transfer Specifications, Coding Guidelines, Post Production Database Change Control Documentation, Database Audit and Lock Procedures

· Work with DB programmers to design (e)CRFs and edit checks in EDC system for complex studies

· Lead, coordinate, and perform User Acceptance Testing (UAT) tasks for complex studies and modules

· Ensure proper completion of QC and UAT of EDC tools and modules, including database testing, data export testing, and testing of custom programming

· Coordinate with Sponsor and Vendors to ensure efficiency and quality of electronic data receipt, integration, and reconciliation

· Troubleshoot technical issues as appropriate

· Design “smart” listings and study-specific processes for effective data review, query issue and resolution

· Manage queries and trends to ensure data completeness and integrity

· Perform coding of adverse events, medical conditions and medications.

· Perform SAE reconciliation

Skills:

EDC, uat testing, uat, CRO, vendor management, crf

Additional Skills & Qualifications:

ideally looking for a high-level Senior person coming from a CRO

this person would have 2-5 direct reports

Must haves:

CRO experience

Bachelor's degree

10 years of hands on DM experience, 2 years of management experience

60% hands on DM, 40% oversight

Ability to build an eCRF from scratch!

UAT experience with or w/o scripts

Experience Level:

Expert Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.