Advarra

Manager

• Draft and negotiate a variety of contracts, including master agreements (containing SaaS subscription terms) data privacy agreements, statements of work, software user agreements, business associate agreements, and consulting services arrangements
• Coordinate with internal and external subject matter experts, including external counsel when needed
• Drive the contracting process and serve as point of contact for internal stakeholders and customers
• Respond to inquiries regarding contract interpretation and compliance
• Support continuous improvement of internal processes
• Establish and build good working relationships with internal clients, based on mutual trust and respect, as well as knowledge of the company’s business, needs, and goals
• Work on additional legal or contracting projects as directed
• Maintain contractual records and documentation
• Participate in training new staff
• Other duties as assigned

Contracts Manager

Learning and Development

• Develop and deliver professional training events for customers and internal employees; demonstrate expertise in our software products as well as an understanding of customer workflows and unique configurations
• Create and update training documentation, which includes training manuals, assessments, diagrams, PowerPoints, and other supporting materials
• Serve as designated product owner for at least one Advarra technology product and be responsible for ensuring all training materials are updated to match the product release schedule
• Become a software expert in multiple Advarra software application(s); stay up-to-date on new features and version changes
• Develop an understanding of the clinical trial industry, including typical customer processes and standard operating procedures; provide guidance and share best practices with customers
• Assist with administration of our Learning Management System, including advanced user access support across all LMS portals
• Serve as an internal consultant to analyze teams’ training needs; suggest and lead projects to improve internal training and meet teams’ needs
• Identify ways to improve existing training processes; suggest changes to enhance the customer and internal stakeholders’ training experience with Advarra
• Conduct both in-person and web-based training events
• Collaborate with eLearning team to develop new training offerings for various audiences and products
• Provide product demonstrations to support the needs of the existing customer base and the business development team
• Observe training sessions and provide feedback to other trainers, to help them develop new skills and strategies for training adults on software products
• Be an active member of the Advarra community by preparing and conducting sessions for large groups at our industry conferences and regularly posting and responding in the community forum
• Demonstrate responsiveness and sense of urgency in all customer interactions
• Document bugs discovered in the system for future development
• Regularly incorporates feedback into updating training offerings and documentation
• Perform other job-related duties as assigned

Senior Training Specialist

Analyst

• Design, evaluate, and manage global compensation programs, policies, and frameworks
• Establish and maintain governance, standards, and guidelines
• Contribute to development of global salary structures, incentive plans, and job architecture
• Lead global benchmarking and market analysis using Radford and other sources
• Develop and maintain enterprise-level compensation models (merit cycles, bonus funding)
• Define process frameworks, timelines, and governance for global compensation cycles
• Drive continuous improvement of compensation processes, tools, and technologies

Senior Global Compensation Analyst

• Draft and negotiate a variety of contracts, including master agreements (containing SaaS subscription terms), data privacy agreements, statements of work, software user agreements, business associate agreements, and consulting services arrangements
• Coordinate with internal and external subject matter experts, including external counsel when needed
• Drive the contracting process and serve as point of contact for internal stakeholders and customers
• Respond to inquiries regarding contract interpretation and compliance
• Support continuous improvement of internal processes
• Establish and build good working relationships with internal clients
• Work on additional legal or contracting projects as directed
• Maintain contractual records and documentation
• Participate in training new staff
• Other duties as assigned

Editor

• Supports the IRB Services department in the review of incoming submissions and preparation of informed consent forms (ICFs) used in the conduct of human subjects research.
• Conduct an accurate pre-review of new and revised consent forms in regulatory compliance with applicable FDA, HHS, Health Canada, TCPS2 regulations, ICH GCP guidance, and operational compliance with Advarra Standard Operating Procedures and Work Instructions.
• Edit new and revised consent forms to ensure regulatory compliance and alignment with Advarra operational standards.
• Apply negotiated Sponsor and site language to consent form documents as required by client agreements documented in mandatory language documents or MLD’s.
• Collaborate with Board members and staff to include all necessary edits to the consent form from the various stakeholders.
• Complete informed consent quality control check for yourself and others.
• Mentor new team members, as requested.
• Maintain and increase individual regulatory knowledge to assist with organizational compliance.
• Complete standard Human Subjects Research Training, such as CITI, on a repeating cycle determined by management.
• Complete organizational training as required by management.
• Attend one IRB meeting per month to enhance knowledge and understanding of IRB processes (two meetings per month during the initial training period).
• Offer process improvement suggestions to management, as applicable.
• Other duties as assigned.

Senior Editor, Consent Form Development

IT Support

• Promote client loyalty through excellent customer service and assistance with clinical research study activities
• Work within a team on pooled work to meet service objectives and team goals
• Identify and service the needs of customers through building rapport and resolving routine service questions
• Answers and addresses inquiries from Advarra clients via Zendesk and incoming phone calls in a courteous, timely and professional manner: Identifies customer issue or question, providing accurate and timely resolution
• Empathizes with the customer establishing expectations for resolution to his/her inquiry
• Works with key members within department and across the company in providing customer focused resolution
• Follows up with customers within established expectations and timeline
• Performs data entry and administrative tasks to process time-sensitive documents requiring high accuracy, completeness, and adherence to strict guidelines
• Processes CIRBI Gatekeeper assignments and Account Profile assignments in an accurate and timely manner following company guidelines
• Handle varying tasks on a routine basis while ensuring high company and industry standards
• Executes procedures in compliance with internal quality standards and external regulations
• Handles changing priorities with flexibility and adaptability
• Works collaboratively with other team members and others across departments to meet project and work deadlines
• Additional duties as assigned by department management as required by the needs of the company

Help Desk Coordinator I

• Supports the IRB Services department in the review of incoming submissions and preparation of informed consent forms (ICFs)
• Conduct an accurate pre-review of new and revised consent forms in regulatory compliance
• Editing new and revised consent forms to ensure regulatory compliance
• Collaborating with Board members and staff to include all necessary edits to the consent form
• Keeping up to date with U.S. and/or Canadian Regulations and Guidelines in Human Subject Protections
• Completing standard Human Subjects Research Training, such as CITI
• Attending one IRB meeting per month to enhance knowledge and understanding of IRB processes

Editor I, Consent Form Development

• Supports the IRB Services department in the review of incoming submissions and preparation of informed consent forms (ICFs) used in the conduct of human subjects research
• Conduct an accurate pre-review of new and revised consent forms in regulatory compliance
• Edit new and revised consent forms to ensure regulatory compliance and alignment with Advarra operational standards
• Collaborate with Board members and staff to include all necessary edits to the consent form from the various stakeholders
• Mentor new team members, as requested
• Maintain and increase individual regulatory knowledge to assist with organizational compliance

• Supports the IRB Services department in the review of incoming submissions and preparation of informed consent forms (ICFs)
• Conduct an accurate pre-review of new and revised consent forms in regulatory compliance with applicable FDA, HHS, Health Canada, TCPS2 regulations, ICH GCP guidance, and operational compliance with Advarra Standard Operating Procedures and Work Instructions
• Editing new and revised consent forms to ensure regulatory compliance and alignment with Advarra document standards
• Applying negotiated Sponsor language to consent form documents as required by client agreements documented in mandatory language documents or MLD’s
• Collaborating with Board members and staff to include all necessary edits to the consent form from the various stakeholders
• Keeping up to date with U.S. and/or Canadian Regulations and Guidelines in Human Subject Protections, drug research, device research, and cosmetic research
• Completing standard Human Subjects Research Training, such as CITI, on a repeating cycle determined by management
• Completing organizational training as required by management
• Attending one IRB meeting per month to enhance knowledge and understanding of IRB processes (two meetings per month during the initial training period)

Project Manager

• Successful completion of projects on-time, with appropriate resources, to high quality levels and at a rate that supports the company’s business plan
• Proven track record of implementing, running and delivering successful projects.
• Management of cross-functional teams to projects, coordinating with functional heads
• Coordinate the assignment of resources with other project managers through maintenance of a project “master schedule”
• Develop project schedules for all projects and communicate clearly to teams (each team member should know what they need to do and when they need to do it)
• Ensure up-front pre-requisite items are in place to support the project (e.g. client deliverables, customer requirements/solution specification, etc).
• Ensure daily/weekly project communication via meetings, etc. take place.
• Strive to keep the teams motivated, informed, mutually supportive, and working towards a common objective
• Monitor project progress real-time to pick up and resolve problems early
• Ability to display a high degree of professionalism in dealing with customers
• Liaise with customer, and Client Success/Strategic Partners, to resolve open issues/queries which are blocking the team’s progress
• Ongoing reporting to senior management on the health status of projects
• Provide ongoing feedback to functional heads re the individual performance of team members
• Conduct post-project evaluations and assign ownership of any resulting actions
• Work to constantly enhance the product through encouraging the teams to apply new ideas (interactions, graphics, animations, instructional methods) to ongoing projects
• Continuously work with the teams, leveraging their inputs, to enhance processes in a controlled way through removal of waste, addition of value, and improvements to development tool set
• Training and mentoring team members
• Assist the Project Management, Senior Manager with other duties in an orderly and efficient manner
• Actively contribute to teamwork by being demanding of both self and team.

Project Manager III

• Successful completion of projects on time, with appropriate resources, to high quality levels and at a rate that supports the company’s business plan
• Management of cross-functional teams to projects, coordinating with functional heads
• Coordinate the assignment of resources with other project managers through maintenance of a project “master schedule”
• Develop project schedules for all projects and communicate clearly to teams (each team member should know what they need to do and when they need to do it)
• Ensure up-front pre-requisite items are in place to support the project (e.g. client deliverables, customer requirements/solution specification, etc.).
• Ensure daily/weekly project communication via meetings, etc. take place.
• Strive to keep the teams motivated, informed, mutually supportive, and working towards a common objective
• Monitor project progress real-time to pick up and resolve problems early
• Liaise with customer, and Client Success/Strategic Partner, to resolve open issues/queries which are blocking the team’s progress
• Ongoing reporting to senior management on the health status of projects
• Provide ongoing feedback to functional heads re the individual performance of team members
• Conduct post-project evaluations and assign ownership of any resulting actions
• Work to constantly enhance the product through encouraging the teams to apply new ideas (interactions, graphics, animations, instructional methods) to ongoing projects
• Continuously work with the teams, leveraging their inputs, to enhance processes in a controlled way through removal of waste, addition of value, and improvements to development tool set
• Actively contributes to teamwork by being demanding of both self and team
• Assume individual responsibility for own deliverables and deadlines
• Assume collective responsibility for successful on-time completion of projects
• Be supportive and constructively critical of team members. In return, be open to the support and criticism offered by your colleagues

Project Manager II

• Successful completion of projects on-time, with appropriate resources, to high quality levels and at a rate that supports the company’s business plan
• Proven track record of implementing, running and delivering successful projects
• Management of cross-functional teams to projects, coordinating with functional heads
• Coordinate the assignment of resources with other project managers through maintenance of a project “master schedule”
• Develop project schedules for all projects and communicate clearly to teams (each team member should know what they need to do and when they need to do it)
• Ensure up-front pre-requisite items are in place to support the project (e.g. client deliverables, customer requirements/solution specification, etc.)
• Ensure daily/weekly project communication via meetings, etc. take place
• Strive to keep the teams motivated, informed, mutually supportive, and working towards a common objective
• Monitor project progress real-time to pick up and resolve problems early
• Ability to display a high degree of professionalism in dealing with customers
• Liaise with customer, and Client Success/Strategic Partners, to resolve open issues/queries which are blocking the team’s progress
• Ongoing reporting to senior management on the health status of projects
• Provide ongoing feedback to functional heads re the individual performance of team members
• Conduct post-project evaluations and assign ownership of any resulting actions
• Work to constantly enhance the product through encouraging the teams to apply new ideas (interactions, graphics, animations, instructional methods) to ongoing projects
• Continuously work with the teams, leveraging their inputs, to enhance processes in a controlled way through removal of waste, addition of value, and improvements to development tool set
• Training and mentoring team members
• Assist the Project Management, Senior Manager with other duties in an orderly and efficient manner
• Actively contribute to teamwork by being demanding of both self and team
• Assume individual responsibility for own deliverables and deadlines
• Assume collective responsibility for successful on-time completion of projects
• Be supportive and constructively critical of team members

• Responsible for delivering projects on time and within cost whilst meeting client’s specifications
• Coordinate team members across functional boundaries and act as the communication link to the client study team
• Strive to improve production processes by reducing lead times and costs
• Manage cross-functional teams to projects and coordinate with functional heads
• Develop project schedules and ensure daily/weekly project communication occurs
• Monitor project progress real-time to resolve problems early
• Liaise with customers to resolve issues blocking team progress
• Provide ongoing feedback to functional heads about team members
• Conduct post-project evaluations and encourage team input for process enhancement.

Customer Success Manager

• Monitor and action client requests pertaining to the maintenance and optimization of their study-specific SC platforms and overall SC experience
• Work to resolve all client requests in a timely manner, continually keeping the client informed throughout the resolution process
• Be an expert in how to manage and resolve different query types
• Be an expert in using the essential Live Study toolset – Zendesk, JIRA, Salesforce, Business Intelligence Analytics (Tableau), Pendo reports
• Collaborate with team mates to best resolve new or complex client requests, updating the Live Study knowledgebase as appropriate
• Work with team mates to continually improve our ability to optimize the client experience e.g. maintaining knowledge articles, improving response process, improving the Live Study toolset
• Be an expert in the features and functionality of the SC platform from the perspectives of the three core stakeholder groups – study teams, site staff, and patients
• Communicate with clients promptly, professionally, and cordially.
• Encourage an environment where clients “get to know” the team
• Strive to achieve and exceed Live Study SLAs
• Prepare and distribute monthly Study Review reports and quarterly Account Review reports
• Present to clients at handover calls, from Implementation to Live Study
• Host ad-hoc client meetings to assist clients with troubleshooting, inquiries, and issue resolution

Contracts Manager

Senior Training Specialist

Senior Global Compensation Analyst

Contracts Manager

Senior Editor, Consent Form Development

Help Desk Coordinator I

Editor I, Consent Form Development

Senior Editor, Consent Form Development

Help Desk Coordinator I

Editor I, Consent Form Development

Project Manager III

Project Manager II

Project Manager III

Project Manager II

Client Success Associate