Lead Clinical Data Manager

Company Name

Indivior

Job Overview

Reports To: VP Clinical & Data Sciences
Location: Remote US

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 500 individuals globally. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior.

Position Summary

The Lead Clinical Data Manager is responsible for all Clinical Data Management activities for Indivior: developing and implementing DM procedures and standards, managing DM vendors, systems and resources, overseeing data management activities, identifying most efficient sourcing model, future technology strategies to support Indivior clinical programs/submissions and ensure accurate, complete data acquisition, and integration.

Essential Functions

The responsibilities of this role include, but are not limited to, the following:

• Develop, communicate and execute the data management vision and strategy, including optimum sourcing model, and clinical data acquisition/integration/reporting strategy
• Coordinate DM budget and resource needs
• Oversee/lead review of Data Management activities/outputs (vendor selection and oversight, eCRF development, EDC build, Edit Checks, UAT, Data collection/cleaning, data review, SDTM/CDASH development, DB lock) to ensure clinical programs are executed and reported within agreed upon timelines, budget and quality standards.
• Oversee reconciliation of external data sources.
• Partner with Pharmacovigilance colleagues to perform reconciliation of serious adverse events and other trial-specific events, as required.
• Lead the development and roll out of DM related SOP and Standards (eCRF, Edit Checks, etc)
• Collaborate and ensure DM vendor and contractors successfully collaborate with other functional areas to manage DM activities in order to meet the company goals and clinical program objectives
• Serve as Data Management representative at trial specific meetings and as primary contact for data management vendors, utilizing key performance indicators, metrics, and timelines to assess vendor quality and performance. Escalate issues as needed.
• Understand and stay abreast of Industry Standards in Data Management (data acquisition, integration, review, documentation)
• Demonstrate knowledge of the regulatory requirements as they relate to Data Management, including Data Management systems and data reporting (i.e. CDISC/CDASH)
• Train, coach and oversee external staff – Ensure staff complies with company policies/SOPs and external regulations

Minimum Qualifications

• Master/Bachelor degree of Science with at least 7 years (10 years preferable) of experience in pharmaceutical or biotech industry
• Advanced knowledge in all aspect of Clinical Data Management, industry standards and practices in clinical data management, databases, including 21CFR part 11, 21CFR part 812, ISO 14155 and CDISC/CDASH standards
• Advanced knowledge of Data Management systems (OC-RDC Medidata Rave is a plus), and Centralized/ Risk Based Monitoring
• Knowledge of medical terminology, MedDRA and WHODrug dictionaries, and database design concepts.
• Working knowledge of and experience implementing CDISC CDASH / SDTM / ADaM standards.
• Experience in drug development; working knowledge of ICH, FDA, CFR, GCP, HIPAA, GCDMP, and other regulatory authority guidance.
• Experience in Opioid Use Disorder is a plus
• Experience in vendor management

Competencies/Conduct

In addition to the minimum qualifications, the employee will demonstrate:

• Ability to manage teams, directly and in a cross-matrixial environment
• Demonstrate excellent communication (written and verbal) skills
• Demonstrate problem solving and organizational skills
• Experience in managing multiple studies and being able to prioritize work.
• Experience in drug development and interaction with Regulatory Authorities
• Ability to interact with all levels of management
• Inspire others to excel
• Ability to build network and relationship
• Communicate with impact

Benefits

Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:

• 3 weeks’ vacation plus floating holidays and sick leave, plus company closure from December 24th- January 1st
• 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay
• U.S. Employee Stock Purchase Plan- 15% Discount
• Comprehensive Medical, Dental, Vision, Life and Disability coverage
• Health, Dependent Care and Limited Purpose Flex Spending and HSA options
• Adoption assistance
• Tuition reimbursement
• Concierge/personal assistance services
• Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage
• Gym, fitness facility and cell phone discounts

Guiding Principles

Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.

Compliance Obligations

Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to:

Employee Obligations

• Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
• Risk IQ: Know what policies apply to your role and function and adhere to them.
• Speak Up: If you see something, say something.

Manager Obligations

• Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
• Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.
• Model and reinforce a Speak Up culture on your team.

The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.

EQUAL EMPLOYMENT OPPORTUNITY

EOE/Minorities/Females/Vet/Disabled