Labcorp Associate Adjudication Project Manager in Topeka, Kansas
The Associate Adjudication Project Manager can be either office based or home based.
Manage conduct of all aspects of contracted adjudication start-up activities for assigned project(s), including but not limited to:
Compiling adjudication committee membership
Developing the Adjudication Committee Charter
Developing the Site Manual
Developing the Adjudication Services Operational Plan
Developing workflows and data capture forms
Developing tracking tools and reports
Developing and delivering project-specific training to stakeholder groups (e.g. Adjudication Services staff, project team members, client staff, adjudicators, sites).
Provide ongoing functional project management of Adjudication Services scope of assigned project(s). This includes, but is not limited to, oversight of the following activities:
Providing oversight of Adjudication Services team activities pertaining to: deliverables, procedures, timelines, scope of work, budget, quality, productivity and profitability.
Assigning project work to supporting team members.
Monitoring workflow and project status to ensure all deliverables and deadlines are met; making adjustments and escalating potential issues to relevant individuals, as appropriate.
Managing any vendors contracted to support Adjudication Services.
Reviewing and distributing event adjudication status reports and metrics to relevant stakeholders.
Providing input into client invoicing and vendor payment.
Serving as central point of contact and communications, representing Adjudication Services on assigned project(s).
Interfacing regularly with customers, both internal and external (including adjudicators).
Attending internal and client team meetings.
Conducting and minuting Adjudication Services team meetings.
Coordinating, conducting and minuting relevant sessions of adjudication meetings.
Ensuring compliance with project budget, actively identifying out of scope work and escalating potential scope changes to appropriate individuals.
Ensure that team members operate in accordance with the Adjudication Services Operational Plan in place on assigned project(s).
Manage execution of all aspects of the workflow pertaining to the processing of events for adjudication on assigned project(s). This includes, but is not limited to, oversight of procedures for:
Maintaining event tracking systems.
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.
Contacting site personnel to obtain missing data and/or documents.
Escalating open events for issue resolution and closure, in accordance with relevant Escalation Plan.
Completing First Review QC Checklists, assembling dossiers.
Completing Second Review QC Checklists.
Conducting event reconciliation processes.
Manage implementation of adjudicator workflows on assigned project(s). This includes, but is not limited to:
Implementation of adjudicator disagreement resolution processes.
Implementation of re-review and re-adjudication processes.
Processing of adjudicator requests for additional documentation.
Processing of adjudicator notifications of potential un-reported events.
Perform periodic and final project file reviews on assigned project(s) and ensure any findings are addressed.
Provide mentoring and/or training for less experienced Adjudication Services staff on assigned project(s), as appropriate.
Liaise with Adjudication Services management to ensure adequate resources are available for assigned projects.
Perform project risk assessments and formulate actions to manage risk.
Work in accordance with the Standard Operating Procedure (SOP) system, including departmental Work Instructions (WIs).
Build and maintain good working relationships within the Adjudication Services department and across functional units.
Any other duties as assigned by management.
Level of education required (or experience level which may be substituted for level of education):
BS/BA Degree + 5 years relevant experience* (or 5 years adjudication experience), including at least 3 years of team leadership experience*
MS/MA Degree + 4 years relevant experience (or 4 years adjudication experience), including at least 3 years of team leadership experience
RN + 3 years relevant experience (or 3 years adjudication experience), including at least 3 years of team leadership experience
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.
*Team leadership experience includes experience bearing overall responsibility for work products generated for customers by supporting team members operating in matrix environment, assigning and coordinating work executed by a team of supporting staff, organizing efforts of more than one individual to achieve common team objectives. For the purposes of this job description, line management of direct reports can be considered equivalent to team leadership experience.
Good knowledge of project management lifecycle, processes and tools.
Good knowledge of time and cost estimate development.
Ability to provide strong mentorship and guidance to junior staff.
Ability to coach project leads in development of leadership, communication and project management skills.
Ability to work independently in a high visibility team leadership capacity, in regular consultation with management.
Functions as a positive, engaging and motivating team player.
Ability to effectively balance multiple concurrent priorities in a fast-paced, complex setting.
Ability to effectively manage multiple internal and external customers competing concurrently for attention, services and resources.
Ability to present and share useful business information across departments and functions.
Ability to anticipate and identify problems and take appropriate action to correct.
Ability to interact and influence with line and middle management, staff and external contacts on a functional and tactical level.
Excellent customer focus.
Excellent written and verbal communication skills. Able to express complex ideas and concepts.
Excellent presentation skills.
Knowledge of medical terminology.
Knowledge of hospital documentation practices.
Knowledge of Good Clinical Practice (GCP).
Good understanding of clinical data capture and data analysis practices.
Good understanding of customer management.
Good understanding of financial management.
High degree of accuracy with close attention to detail and ability to perform effective quality control.
Good familiarity with MS Office and Windows applications beneficial.