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Keywords / Skills : Adjudication Project Lead, Good Clinical Practice, pharmaceutical, biotechnology, CRO, Clinical, Safety, Data Management.

3 - 11 years
Posted: 2019-07-24

Industry
Pharmaceutical
Function
Pharmaceutical/Biotechnology
Role
Other Pharma - Project Lead
Posted On
24th Jul 2019
Job Description
Job Overview 

* Participate in all aspects of adjudication start-up activities, including but not limited to: o Compiling adjudication committee membership o Providing review and input into the Adjudication Committee Charter o Developing the Site Manual o Developing the Adjudication Services Operational Plan o Providing review and input into workflows and data capture forms o Providing review and input into development of tracking tools and reports o Developing and delivering project-specific training to limited stakeholder groups (e.g. Adjudication Services staff, project team members, sites).

* Provide ongoing functional leadership for Adjudication Services scope of assigned project(s). This includes, but is not limited to:

* Providing oversight of Adjudication Services team activities pertaining to: deliverables, procedures, timelines, scope of work, budget, quality, productivity and profitability.
  • Assigning project work to suppolting 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.
  • 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. 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 or Second Review QC Checklists (as appropriate), assembling dossiers.
  • Conducting event reconciliation processes.
  • May directly perform QC of assembled dossiers, complete Second Review QC Checklists (as appropriate).
  • Manage implementation of adjudicator workflows. This includes, but is not limited to: o Implementation of adjudicator disagreement resolution processes. o Implementation of re-review and re-adjudication processes. o Processing of adjudicator requests for additional documentation.
  • Processing of adjudicator notifications of potential un-reported events.
  • Perform periodic and final project file reviews and ensure any findings are addressed.
  • Provide mentoring and/or training for less experienced Adjudication Services staff, as appropriate.
  • May participate in bid defenses or other presentations.
  • 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.
Education/Qualifications


Level of education required (or experience level which may be substituted for level of education):
  • Non-Degree + 8 years relevant experience* * (or 8 years adjudication experience*)
  • Associates Degree + 6 years relevant experience (or 6 years adjudication experience)
  • BS/BA Degree + 3 years relevant experience (or 3 years adjudication experience)
  • RN + 1 year relevant experience (or I year adjudication 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.

Experience
  • Ability to work independently in a team leadership capacity, with moderate guidance.
  • Functions as a positive, engaging and motivating team player.
  • Ability to effectively balance multiple concurrent priorities.
  • 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.
  • Good customer focus.
  • Strong written and verbal communication skills. Able to express complex ideas and concepts.
  • Good presentation skills.
  • Knowledge of medical terminology.
  • Knowledge of hospital documentation practices.
  • Knowledge of Good Clinical Practice (GCP).
  • Basic understanding of clinical data capture and data analysis practices.
  • 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.


About Company

Covance India Pharmaceutical Services Private Limited
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