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Sr Adjudication Project Lead

Laboratory Corporation of America Holdings (Covance)

Durham, North Carolina, United States

<h2>Job Overview:</h2><ul><li>Manage all aspects of contracted adjudication start-up activities, including but not limited to:<ul><li>Compiling adjudication committee membership</li><li>Developing the Adjudication Committee Charter</li><li>Developing the Site Manual</li><li>Developing the Adjudication Services Operational Plan</li><li>Developing workflows and data capture forms</li><li>Developing tracking tools and reports</li><li>Developing and delivering project-specific training to stakeholder groups (e.g. Adjudication Services staff, project team members, client staff, adjudicators, sites).</li></ul></li><li>Provide ongoing functional leadership for Adjudication Services scope of assigned project(s). This includes, but is not limited to:<ul><li>Providing oversight of Adjudication Services team activities pertaining to: deliverables, procedures, timelines, scope of work, budget, quality, productivity and profitability.</li><li>Assigning project work to supporting team members.</li><li>Monitoring workflow and project status to ensure all deliverables and deadlines are met; making adjustments and escalating potential issues to relevant individuals, as appropriate.</li><li>Managing any vendors contracted to support Adjudication Services.</li><li>Reviewing and distributing event adjudication status reports and metrics to relevant stakeholders.</li><li>Providing input into client invoicing and vendor payment.</li><li>Serving as central point of contact and communications, representing Adjudication Services on assigned project(s).</li><li>Interfacing regularly with customers, both internal and external (including adjudicators).</li><li>Attending internal and client team meetings.</li><li>Conducting and minuting Adjudication Services team meetings.</li><li>Coordinating, conducting and minuting relevant sessions of adjudication meetings.</li><li>Ensuring compliance with project budget, actively identifying out of scope work and escalating potential scope changes to appropriate individuals.</li></ul></li><li>Ensure that team members operate in accordance with the Adjudication Services Operational Plan in place on assigned project(s).</li><li>Manage execution of all aspects of the workflow pertaining to the processing of events for adjudication. This includes, but is not limited to, oversight of procedures for:<ul><li>Maintaining event tracking systems.</li><li>Event case processing: intake and triage, event linking, event de-activation, tracking, data entry, document processing (e.g. redaction of specified content), review of incoming event information for completeness and accuracy, content review, identification of missing required data and/or documents, generation of queries, query review and closure/re-issue.</li><li>Contacting site personnel to obtain missing data and/or documents.</li><li>Escalating open events for issue resolution and closure, in accordance with relevant Escalation Plan.</li><li>Completing First Review QC Checklists or Second Review QC Checklists (as appropriate), assembling dossiers.</li><li>Conducting event reconciliation processes.</li></ul></li><li>May directly perform QC of assembled dossiers, complete Second Review QC Checklists (as appropriate).</li><li>Manage implementation of adjudicator workflows. This includes, but is not limited to:<ul><li>Implementation of adjudicator disagreement resolution processes.</li><li>Implementation of re-review and re-adjudication processes.</li><li>Processing of adjudicator requests for additional documentation.</li><li>Processing of adjudicator notifications of potential un-reported events.</li></ul></li><li>Perform periodic and final project file reviews and ensure any findings are addressed. </li><li>Provide mentoring and/or training for less experienced Adjudication Services staff, as appropriate.</li><li>May participate in bid defenses or other presentations.</li><li>Work in accordance with the Standard Operating Procedure (SOP) system, including departmental Work Instructions (WIs).</li><li>Build and maintain good working relationships within the Adjudication Services department and across functional units.</li><li>Any other duties as assigned by management.</li></ul><h2>Education/Qualifications:</h2>Minimum Required: Level of education required (or experience level which may be substituted for level of education): <ul><li>BS/BA Degree + 4 years relevant experience** (or 4 years adjudication experience*), including at least 2 years of team leadership experience***</li><li>MS/MA Degree + 3 years relevant experience (or 3 years adjudication experience), including at least 2 years of team leadership experience</li><li>RN + 2 years relevant experience (or 2 years adjudication experience), including at least 2 years of team leadership experience</li></ul> Degree preferred (but not necessary) to be in one or more of the following disciplines: Biological Sciences, Pharmacy, Nursing, Life Sciences, and Chemistry. *Adjudication experience includes direct experience receiving and processing events for adjudication, working to collect event data and documents required for adjudication, working within adjudication event tracking systems. **Relevant experience includes experience in the pharmaceutical, biotechnology, CRO or ARO industry in related areas, such as: Clinical, Safety, Data Management.<h2>Experience:</h2>Minimum Required:<ul><li>Ability to work independently in a high visibility team leadership capacity, with limited guidance.</li><li>Functions as a positive, engaging and motivating team player.</li><li>Ability to effectively balance multiple concurrent priorities in a fast-paced, complex setting.</li><li>Ability to effectively manage multiple internal and external customers competing concurrently for attention, services and resources.</li><li>Ability to present and share useful business information across departments and functions.</li><li>Ability to anticipate and identify problems and take appropriate action to correct.</li><li>Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level.</li><li>Strong customer focus.</li><li>Strong written and verbal communication skills. Able to express complex ideas and concepts.</li><li>Strong presentation skills.</li><li>Knowledge of medical terminology.</li><li>Knowledge of hospital documentation practices.</li><li>Knowledge of Good Clinical Practice (GCP).</li><li>Good understanding of clinical data capture and data analysis practices.</li><li>High degree of accuracy with close attention to detail and ability to perform effective quality control.</li><li>Good familiarity with MS Office and Windows applications beneficial.</li></ul>

Job posted: 2021-11-17

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Sr Adjudication Project Lead

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