Oncology Risk Management Strategist

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Oncology Risk Manager / Oncology Risk Management Strategist

Remote

One year contract

The Oncology Risk Manager will work with the trial teams and/or Program teams to coordinate the identification, assessment, and mitigation of quality risks that could impact on trial data integrity, patient safety, well-being, or rights. Throughout the duration of the trial/program, the Oncology Risk Manager executes data-driven, risk-based trial oversight activities to deliver quality in the execution of clinical trials (and/or programs), compliance with regulatory requirements and internal procedures, and to maintain a continued state of inspection readiness.

Duties & Responsibilities:

Risk Management with minimal direction from the Director, Oncology Risk Management:

·        Actively participates all study activities, contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical team members on effective mitigation strategies.

·        Leads regular review of risk areas in collaboration with Risk Owners, to evaluate progress of risk mitigations and risk reduction, and to identify potential new risks or additional mitigation needs (trial and/or compound, as assigned).

·        Maintains IQP (Integrated Quality Plans) risk monitoring information in quality risk repository to facilitate regular progress reviews.

·        Independently drives quality risk monitoring reviews and coaches others on risk monitoring and mitigation reviews.

·        Communicates and facilitates risk updates to R&D Business Partners as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable (trial and/or compound, as assigned).

·        Highlight new potential systemic risk to QP&S management.

Issue Consultation, Issue Escalation, and Compliance Assessment:

·        Develops and ensures a consistent interpretation of issues that require quality investigations.

·        Provides guidance for significant quality issues (SQI) per corporate standards and escalates SQI to senior R&D management.

·        Provides initial serious breach evaluation of quality issue that may require reporting to Health Authorities.

·        In collaboration with partners, provides advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self – Identified, Inspection, Audit).

Submission Support: Pre-submission Quality Stage Gate Review (SGR):

·        Leads the Cross-Functional Trial Team and other key contributors in SGR content development & follow-up Activities.

·        Coaches and mentors other team members on SGR for coordination and management of activities.

Inspection Readiness and Support:

·        Drives ongoing inspection readiness activities with trial teams to develop inspection narratives, identify and prepare sites of interest for inspection (including, pre-inspection visit support), ensure availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams.

·        Provides front and back room support for Sponsor-Monitor inspections, including post inspection support. Provide inspection support per contractual agreement for third party inspections (vendors, co-development partners and contract research organizations).

·        Provides remote support for investigational site inspections including post inspection support.

·        Provides supervision and/or coaching for others on inspection support and readiness.

Consultancy:

·        Provides independent advice on questions related to research quality and compliance from Business Partners in collaboration with other Quality Professionals and Subject Matter Experts to ensure consistent interpretation of international regulations and policy.

Post-licensing and Acquisition (L&A) / Integration:

With the guidance from the QP&S L&A Team and Oncology Head or Delegate:

·        Support the coordination of the quality integration of the acquiring asset or company/partner and deliver robust documentation within the program/trial integration plans (90-day plan) and execute assigned responsibilities per plan.

·        Provide general guidance to stakeholders.

·        As required, provide input into Quality Agreements with (Co-)development Partners and execute responsibilities per agreement.

·        Supports and facilitates asset divestment

Other Duties:

·        Participates in QP&S, cross-functional, or cross-sector working groups to develop or refine processes, tools, and systems that deliver innovative quality solutions (as a team member or workstream/project lead).

·        Works with limited supervision, independently making decisions for compounds and studies.

·        Provides training and coaching to peers and new employees, as needed.

Qualifications:

Required:

·        BA/BS or equivalent (Scientific, medical, or related discipline).

·        A minimum of 8 years of experience working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system) required.

·        Proficiency in Microsoft Office Applications.

·        Proficiency in speaking and writing English.

·        Excellent interpersonal, oral, and written communication skills.

·        Proven strong GCP quality and/or clinical trials experience.

·        Experience collaborating in a cross-functional team environment.

·        Flexibility to respond to changing business needs.

·        Demonstrates ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures.

·        Travel up to 10%, primarily domestic travel with some international travel.

Preferred:

·        Advanced degree preferred in Scientific, medical, or related discipline.

·        Healthcare industry (pharmaceutical industry and/or healthcare/hospital system) experience.

·        Knowledge of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP).

·        Specific Oncology experience may be required depending on the position.

·        Experience with fundamentals of clinical trial risk management.

·        Global clinical trial experience.

·        Experience working in a Quality function (Quality Management, Quality Assurance/Control and / or Compliance).

·        Experience working to ICH guidelines.

·        Health Authority Inspection experience (FDA, EMA and other inspectorates).

·        Strong Project Planning/Management skills.

·        Experience and/or proficiency with data analytics and/or data visualization tools (i.e., Tableau, Spotfire, or related).

·        Proven ability to analyze & interpret collective data to provide insights to drive decision-making.

·        Experience in managing escalations and CAPA support/advisement.

·        Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease).

For over 16 years, Medasource has established and maintained relationships that are designed to meet your IT staffing needs. Whether it’s contract, contract-to-hire, or permanent placement work, we customise our search based upon your company’s unique initiatives, culture and technologies. With our national team of recruiters placed at 21 major hubs around the nation Medasource finds the people best-suited for your business. When you work with us, we work with you. That’s the Medasource promise.

Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

Benefits & Perks:

Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

Pay Disclaimer:

The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.

JO-2410-152342

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