Job Description

JOB DESCRIPTION
JOB RESPONSIBILITIES:

Adherence to SOPs and maintaining audit-ready documentation.

Coordinate and oversee activities of all DM staff assigned to the project, ensuring
high quality, respecting project timelines and adherence to the budget.

Attend relevant project meetings and work closely with other internal and external
leads.

Liaise with client/partners for clarification on any clinical and / or technical decisions
and propose most efficient solutions.

Identify risks to project deliverables and timelines, develop and implement the
mitigations for these risks.

Create DM timelines for database set-up.

Lead and participate in the design of Clinical Electronic Data Capture (EDC)
components including mock CRF, casebook, edit checks.

Coordinate and create data management documentation including Data Management

Plan, Data Validations Specifications, eCRF Completion Guidelines, Data Collection
System Configuration, Data Transfer Agreement.

Coordinate and perform User Acceptance Testing.

Train EDC users.

Manage EDC users’ access and assist with resolving issues.

Coordinate all conduct Data Management tasks.

Lead and participate in data cleaning activities including SAE and external data
reconciliation.

Provide input to protocol and assess database impacts based on protocol changes
during study lifecycle; prepare and execute change request forms.

Lead and participate in Database Lock activities, including timelines creation, QC
coordination and Data Management Report creation.

Contribute to departmental procedures and guidelines.

Critically evaluate data management needs and propose appropriate, innovative, and
efficient data management solutions.

Train and mentor less experienced staff.

Represent Cytel at project, proposal, or industry meetings.

May participate in the recruitment process.

Contribute to budget evaluation for proposal writing purpose and be Data
Management representative during bid-defense, as needed.

Support senior team members and/ or be the data management representative
during audits.

May act as a line manager, contribute to the development of a strong team of data
managers, by functionally managing and guiding the data managers with respect to data management strategy, deliverables, processes, and professional development.

Job Tags

Permanent employment,

Similar Jobs

Zaxby's

Cook-Nightime Job at Zaxby's

Hungry For A Great Career? To our guests, Zaxbys is more than just a place to eat its a place to have fun, spend some time with friends and experience great food. To our team members, Zaxby's is a family. So come on in! We're saving a seat for you. Position Overview...

HighKey Agency

YouTube Video Editor Job at HighKey Agency

YouTube Video Editor (Long-Form + VFX) HighKey Agency is a digital PR and social media company specializing in building elite personal and brand presences in the aesthetic industry, from top-tier plastic surgeons to high-growth med spas. We engineer content systems...

Knowhirematch

Tax Credit Specialist - R&D Focus (CPA Firm) Job at Knowhirematch

...involvement in federal and state R&D tax credits . Minimum 1 year of supervisory experience (mentoring or directing tax staff). CPA license (active or in process). Commitment to professional development with at least 40 hours of continuing education annually....

Direct Demo LLC

$22 TO $25/HR SALES REPRESENTATIVE COSTCO, STATEN ISLAND Job at Direct Demo LLC

DIRECT DEMO is looking for a sales representative to join our team in our Staten Island office. This person will actively seek out and engage prospective customers to sell our product and/or services. The ideal candidate is results-driven, hungry for customer acquisition...

Essentia Health

Physician - Radiation Oncology - Fargo, ND Job at Essentia Health

**Licensure/Certification Qualifications:****Radiation Oncologist Opportunity - Join a Thriving, Patient-Centered Practice****Location... ...(1.0 FTE)Are you ready to elevate your career in Radiation Oncology? Essentia Health is seeking a compassionate and driven **Radiation...

Principal Clinical Data Manager Job at Cytel - EMEA, Cambridge, MA

TU9RbWgrSFlkQ2Z6RktHbFRZVmlBVjRO