Job Description

\xc2\xa8 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. \xc2\xa8 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. \xef\x82\xa8 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. \xef\x82\xa8 Run metrics and KPIs as appropriate for the operations team to review for productivity, quality and on time delivery. \xef\x82\xa8 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. \xef\x82\xa8 Support internal initiatives for operations department.Work with Line Manager on staff assignments and trainings for staff. \xc2\xa8 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. \xef\x82\xa8 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. \xef\x82\xa8 Ensure that all allocated projects are carried out in strict accordance with the relevant protocols, Covance global harmonized SOPs or client SOPs, and the specified standards of GCPs. \xef\x82\xa8 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. \xef\x82\xa8 Assist or lead the internal and external Data Management meetings. \xef\x82\xa8 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) \xef\x82\xa8 Keeps LDM and internal operational team informed of pertinent project or sponsor related information (i.e., work scope changes, timeline impacts). \xef\x82\xa8 Ensures study specific Data Transfer Agreements are put in place for all ancillary data vendors involved in the study. \xef\x82\xa8 Track scope changes and work with the Lead DM to ensure that Sponsor approval is received, and the scope change processed. \xef\x82\xa8 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. \xef\x82\xa8 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. \xef\x82\xa8 Coordinate with DM study team to ensure the receipt and inventory of all data related information is delivered within agreed upon timelines. \xef\x82\xa8 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. \xef\x82\xa8 Assist or coordinate the internal or external meetings as appropriate. \xef\x82\xa8 Attend client or internal audits as appropriate and resolve all issues within an appropriate timeframe. Address client comments with the study team. \xef\x82\xa8 Assist or provide reports to Sponsor and internal team as dictated by project need. \xef\x82\xa8 Assist or lead with the completion of Database Lock and Unlock activities with LDM. \xef\x82\xa8 Post Data Management documentation and data management related administrative tasks as requested, including maintenance of eTMF as required. \xef\x82\xa8 Performs other related duties as assigned by Line Management. Minimum Required: \xef\x82\xa8 6 to 8 years of DM experience. \xef\x82\xa8 Experience in handling customer concerns and experience with managing Scope of Work and budgets is preferred. \xef\x82\xa8 Knowledge of clinical trial process, DM, clinical operations, biometrics, and system applications to support operations. \xef\x82\xa8 Time management skill and ability to adhere to project productivity metrics and timelines. \xef\x82\xa8 Ability to work in a team environment and collaborate with peers. \xef\x82\xa8 Good organizational ability, communication, and interpersonal skills. \xef\x82\xa8 Team working skills and good collaborator skills. \xef\x82\xa8 Knowledge of medical terminology. \xef\x82\xa8 Knowledge of science or a scientific background is preferred. Education/Qualifications

• University / college degree (life sciences, health sciences, information technology or related subjects preferred).

\xef\x82\xb7 Experience and/or education plus relevant work experience, equating to a bachelor\'s degree will be accepted in lieu of a bachelor\xe2\x80\x99s degree. Fluent in English, both written and verbal. Required: \xef\x82\xb7 Focus on Customers. \xef\x82\xb7 Innovate and Change. \xef\x82\xb7 Pursue Scientific and Process Excellence. \xef\x82\xb7 Work with Others. \xef\x82\xb7 Achieve Results. Labcorp is proud to be an Equal Opportunity Employer: As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply. For more information about how we collect and store your personal data, please see our Privacy Statement.