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

Burchfield Penney Art Center

Grants Manager Job at Burchfield Penney Art Center

...Burchfield Penney has a remarkable history and is a crucial member of the Buffalo cultural community. Position Summary: The Grants Manager (GM) is a key position in the Burchfield Penney Art Center Advancement Department, ensuring that the Art Center maintains and...

TradeJobsWorkForce

United Airlines Aircraft Cleaner Job at TradeJobsWorkForce

...Were looking for a United Airlines Aircraft Cleaner to clean cabins and prepare aircraft for boarding. Interact with customers and colleagues in a professional manner. Ensure all safety and quality standards are met. Perks include competitive pay, flexible scheduling,...

Caise Logistics Inc

Delivery Driver FedEx Job at Caise Logistics Inc

...willing to take DOT physical Must be willing to submit a criminal background check Job Summary: Caise Logistics, a contractor with FedEx Ground, has IMMEDIATE OPENINGS for delivery drivers in West Lebanon, NH. Our delivery drivers will be delivering local residents and...

Regional School Unit 13

School Bus Drivers (CDL required with School Bus endorsement) Job at Regional School Unit 13

...purpose of maintaining a safe environment while traveling. School Bus Drivers work a school year schedule, with the option for summer driving and extra trips (i.e. sports, field trips, after-school programming). The position offers a comprehensive benefits package that...

Insight Global

Project Architect Job at Insight Global

Job Description Job Description 6-month contract to hire: 5 days a week onsite What Youll Do Perform architectural assignments with general direction,with limitedimmediate supervision, and work independently as well as collaboratively with others toward design...

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

TVFWMkNuK2VvdEpGUElianhDUFpkN1c2