Ref #: 28825

Employment type: Permanent - Full-Time

Location: US - NC - remote

Posted: 29-Apr-2021

Description

Looking to achieve the next great step in your career! ICON has some exciting opportunities within Data Managements that are dedicated to one sponsor! We are looking for a Sr. Data Manager focusing on project management/oversight of the data management team. – Multiple openings

Overview:

Senior Data Management - Operations Lead will manage end to end clinical data flow (data acquisition from Case Report Form (CRF) development to Clinical Study Reporting (CSR) and ensures timely project execution, quality data deliverables, and prioritization of all DM milestone delivery.


Responsibilities:
Tasks may include but are not limited to

-Acts as a mentor to less experienced DM peers and vendor data management team members, possesses strong knowledge of DM trial execution processes, manages complex trials, and is recognized as a DM process subject matter expert.
-Develops study quality plans and ensures adherence and consistent execution across the data flow and within programs.
-Contributes to and/or accountable to update and manage study dashboards, timelines, resource prioritization, and data deliverables.
-Accountable for development of timelines, project management of all end to end data management deliverables in collaboration with cross functional team members and external data vendors on assigned studies:
-Single point of contact for the execution of data management deliverables on assigned trials/programs. Interprets and applies data strategy, ensures use of global/program standards, coordinates and oversees supporting DM personnel, and monitors and reports on overall study progress.
-Accountable for quality/integrity of the data. Ensures high utilization of standards library components (e.g. eCRFs, Edit checks)
-Reviews performance metrics and trends for DM deliverables on assigned studies/programs and ensures most optimal execution. Reports/Escalates issues/risks to Sponsor Portfolio Lead.
-Primary contact between DM and clinical study management teams (SMT). Liaises directly with stakeholders (Biometrics functions, Clinical, Medical, Regulatory Affairs)
-Is recognized as a Subject Matter Expert for DM process, data collection and management, and reporting
-Manages performance and quality issues with external data vendors (3rd party data providers such as labs) and escalates to sponsor DM Portfolio Lead and DM management. Develops appropriate risk mitigation, as needed.


Qualifications:

-Bachelor's degree
-5 + years Clinical Data Management experience.
-Knowledge of clinical trial database technologies and processes.
-Ability to liaise successfully with sponsors.
-Excellent written and oral communication skills.
-Previous experience and proven competence in managing study delivery through full DM lifecycle (planning, start-up, conduct, lock and closeout)
-Robust experience with Medidata Rave and use of Data Review tools such as J-Review or Business Objects required
-Strong project management skills, and ability to effectively lead and collaborate with various business functions project management certified desirable
-Experience working on outsourced clinical trials
-Experience developing and implementing DM process and data standards
-Demonstrated ability to establish effective business process and relationships with external stakeholders, including implementing process change at a vendor



DOCS is the FSP division of ICON Clinical Research. We provide global strategic resourcing and FSP services to the biopharmaceutical and medical device industries. Founded in 1997, DOCS has grown to become the premier resourcing provider for the clinical development industry.

DOCS is an equal opportunity employer - Minorities/Females/Disabled/Veterans and committed to providing a workplace free of any discrimination or harassment.