Ref #: 29115

Employment type: Permanent - Full-Time

Location: North Carolina - remote

Posted: 11-May-2021


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 Lead Clinical Data Manager.


- Provides oversight and accountability for more than one low to moderate complexity trial or one high complexity trial for data management activities. May be a member of more than one project of low to moderate complexity or member of one project of high complexity.
- Takes a leadership role with the CRO, the trial customer(s) and other internal and external partners to establish, align and confirm data management expectations for assigned trial(s).
- Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements, etc.
- With the trial customer, CRO and other functional partners: – Gathers content and integration requirements for eCRF and other data collection tools. – Establishes conventions and quality expectations for clinical data. – Establishes expectations for dataset content and structure. – Set timelines and follow‐up regularly to ensure delivery of all Data Management milestones.
- Performs trial level oversight controls as described in the oversight plan, QC process and work instructions with minimal DML direction.
- Reviews clinical data management documents (including submission package) ensuring appropriate quality, scientific content, organization, clarity, accuracy, format and consistency. Ensures compliance with regulatory guidelines and the documentation matrix.
- Ensures real‐time inspection readiness of all Data Management deliverables for the trial; Participate in Regulatory Agency and internal audits as necessary.
- Plans and tracks content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival. Ensures deliverables are on time.
- Presents and trains at investigator and monitor meetings


- Bachelor’s degree or equivalent, in Health or Science discipline with experience in clinical research.
- 5+ years Data Management experience
- 3+ years study lead experience
- 5+ years clinical trial experience
- Experience working in highly diverse teams within clinical research; cross‐functional, global, multi‐regional.
- Advanced Microsoft Office skills including the ability to manipulate and analyze data.
- Highly organized with excellent written and verbal communication.
- Ability to interpret clinical trial data and present trends to clinical trial team on data.

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.