Labcorp Associate Clinical Data Manager - Remote within US or Canada in Topeka, Kansas
Labcorp Drug Development is seeking candidates for an Associate Clinical Data Manager. The Associate Clinical Data Manager will be remotely (home-based) located anywhere within the United States or Canada.
Assist and lead operations team with Lead DM, including responsibility for the development of the project documentation, system set-up, data validation procedures and processes assigned to more junior staff. Also assist with all data management activities including database lock according to Client quality expectations, project timelines and budgets.
Lead operations team meetings, meeting frequently with the study leads of coding, SAE Recon team, EDS team to ensure that all deliverables are planned, coordinated interdepartmentally, and proactively identifying potential risks and mitigations. Effectively communicating data driven discussions in order to achieve database lock dates with the highest possible data quality.
Report to Lead DM for all tasks regarding operations team status (Coding, Ext Data Specialists, Data Reviewers, SAE recon and User Management Teams). Bring resourcing issues forward for discussion.
Run metrics and KPIs as appropriate for the operations team to review for productivity, quality and on time delivery.
Support monthly budget reviews with units used by operations team for the month. Limited communication with client as Lead DM is the primary contact for DM activities.
Support internal initiatives for operations department. Work with Line Manager on staff assignments and trainings for staff.
Essential Job Duties:
Collaborate and functionally report to Lead DM (LDM) for studies which include but not limited to - combination of healthy and patient populations, multi-site, medium complexity in protocol design or client management requirements.
As a lead data reviewer and support to the lead Data Manager, you will perform all data operational tasks as appropriate to include, but not to be limited to data review and query management to ensure that quality standards (both internal and Sponsor) are achieved.
Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, Labcorp Drug Development global harmonized SOPs or client SOPs, and the specified standards of GCPs.
Work with the LDM to build study milestone timelines and demonstrates capability to read and follow study timelines for on-time deliverables. And capable and knowledgeable on study design to make suggestions to study timelines when warranted.
Assist or lead the internal and external Data Management meetings.
Assist or lead to write, update/review and approve all required trial data management documentation; including, but not limited to:
o Study-specific case report forms
o CRF Completion Guidelines
o Data Management Plan
o Data Quality Checks (edit checks)
Keeps LDM and internal operational team informed of pertinent project or sponsor related information (i.e., work scope changes, timeline impacts).
Ensures study specific Data Transfer Agreements are put in place for all ancillary data vendors involved in the study.
Track scope changes and work with the Lead DM to ensure that Sponsor approval is received, and the scope change processed.
Supports the training of new staff on project specific Data Management processes. Ensures service and quality meet agreed upon specifications per the DMP and scope of work.
Performs QC on all aspects of work performed in DM Operations to ensure that data quality and integrity is maintained. Feedback constructively on relevant issues and initiate process review as appropriate.
Coordinate with DM study team to ensure the receipt and inventory of all data related information is delivered within agreed upon timelines.
Ensure all appropriate documentation and procedures are performed upon project completion for operations team. Assist or lead the managing of the DM study team ensure client satisfaction is achieved through delivery of quality data.
Assist or coordinate the internal or external meetings as appropriate.
Attend client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team.
Assist or provide reports to Sponsor and internal team as dictated by project need.
Assist or lead with the completion of Database Lock and Unlock activities with LDM.
Post Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required.
Performs other related duties as assigned by Line Management.
University / college degree (life sciences, health sciences, information technology or related subjects preferred).
Experience and/or education plus relevant work experience, equating to a bachelor's degree will be accepted in lieu of a bachelor’s degree.
Fluent in English, both written and verbal.
6 to 8 years of DM experience.
Experience in handling customer concerns and experience with managing Scope of Work and budgets is preferred.
Knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations.
Time management skill and ability to adhere to project productivity metrics and timelines.
Ability to work in a team environment and collaborate with peers.
Good organizational ability, communication, and interpersonal skills.
Team working skills and good collaborator skills.
Knowledge of medical terminology.
Knowledge of science or a scientific background is preferred.
Thorough knowledge of Labcorp Drug Development, the overall structure of the organization and Standard Operating Procedures (SOPs).
3+ years of Electronic Data Capture experience.