Adjudication Project Manager

We are currently seeking experienced Adjudication Project Manager within Canada to lead and support our team! This is a remote based role in Canada.

WHAT YOU WILL DO

You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.

Responsibilities:

• Oversee conduct by project lead of all aspects of contracted adjudication start-up activities for assigned project(s)
• 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 and 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 operational oversight of the project lead who is directly responsible for the Adjudication Services scope for assigned project(s).
• Providing oversight of Adjudication Services team activities pertaining to: deliverables, procedures, timelines, scope of work, budget, quality, productivity and profitability.
• 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).
• 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 project leads and team members operate in accordance with the Adjudication Services Operational Plan in place on assigned project(s).
• Oversee execution of all aspects of the workflow pertaining to the processing of events for adjudication on assigned project(s).
• 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.
• Ability to direct, manage, and coordinate the day-to-day efforts of multiple levels of staff.
• Ability to work independently in a high visibility team leadership capacity, which includes effectively balancing multiple concurrent priorities in a fast-paced, complex setting
• Excellent customer focus
• Excellent written and verbal communication skills.  Able to express complex ideas and concepts.
• Good understanding of customer management and financial management
• High degree of accuracy with close attention to detail and ability to perform effective quality control
• Ability to perform project review and process analysis, identify potential risks and process improvements – and take appropriate action
• And all other duties as needed or assigned

Requirements:

• BS/BA Degree + 6 years relevant experience (or 6 years adjudication experience*), including at least 4 years of team leadership experience
• MS/MA Degree + 5 years relevant experience (or 5 years adjudication experience), including at least 4 years of team leadership experience
• RN + 4 years relevant experience (or 4 years adjudication experience), including at least 4 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 within a CRO or Pharma environment

The important thing for us is you are comfortable working in an environment that is:

• Fast paced: where no deviations from the study protocol are allowed, and not meeting a timeline for even few minutes will create a quality issue.
• Changing priorities constantly asking you to prioritize and adapt on the spot.
• Teamwork and people skills are essential for the study to run smoothly.
• Technology based. We collect our data directly into an electronic environment.

Work Environment:

• Work is performed in an office environment with exposure to electrical office equipment.
• Frequent travel to clients/ site locations with occasional travel both domestic and international.

Physical Requirements:

• Ability to sit for extended periods and operate a vehicle safely.
• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
• Regular and consistent attendance.
• Varied hours may be required.

#LI - Remote

Applications will be accepted on an ongoing basis.

Learn more about our EEO & Accommodations request here.