Vacancies Open at FHI 360

Summary of the position:

• The Quality Assurance Manager II assists the Director, QMSS and Director, Quality Assurance, S. A. with the development and implementation of a broad spectrum of quality activities to demonstrate , document, and report compliance with client expectations in accordance with relevant guidelines and regulations.  The Quality Assurance Manager II may also assist with training compliance and document administration by helping to coordinate the flow of documents through ZenQMS, ensuring compliance with training curricula, and tracking and trending associated metrics.

Essential functions:

• Maintain knowledge of current and new regulations and guidelines and assist with their integration into the FHI Clinical Global Quality Management System.  
• In coordination with functional leadership, develop and maintain policies and procedures that align with FHI Clinical’s mission and values, ICH GCP guidelines, and relevant regulations.  
• Develop and implement internal audit plans according to the QMSS Annual Work Plan, performing internal audits as assigned to assess and monitor compliance with FHI Clinical Standard Operating Procedures, Policies, and study-specific plans.
• Develop and implement audit plans as assigned for fulfillment of contractual obligations and vendor qualification requirements.
• Serve as co-host of audits of FHI Clinical, assisting with coordination of documents and presentations prior to, during, and after audits.  Assist with coordination and review of audit responses from various functional areas.
• Serve as a GCP and regulatory resource to the project teams, assisting with quality oversight of projects, including tracking and trending of quality and risk metrics, as assigned.
• Other duties as assigned.

Knowledge, skills, and abilities:

• Knowledgeable in the content and application of clinical research processes, GxP, and other relevant requirements of major regulatory agencies (e.g., FDA, EMA, PMDA, SAHPRA).
• Highly effective oral and written English communication skills.
• Strong time management, follow-up, and organizational skills, with specific emphasis on attention to detail
• Problem solving/process improvement skills with the ability to be part of and own solutions
• Ability to work well independently, as part of a team, and in a coaching role.

Position Requirements:

• Education: Bachelor’s Degree or the equivalent
• Preferred Job-related Experience:  At least 6 years in a clinical research setting with increasing Quality Assurance responsibility is required.  Proficiency with Microsoft Office applications (e.g., MS Word, MS Excel, MS PowerPoint, MS Teams, MS Power BI, as applicable). Experience with ZenQMS or similar document repository system
• Preferences: Experience in a dedicated auditing role.
• Special Position Requirements: valid driver’s license and passport, ability to travel

Physical Expectations:

• Typical office environment.
• Ability to sit or stand for extended periods of time.
• Ability to move 5-15 lbs.

Travel Requirements:

• Expected travel time is 25% for this position. 

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• Summary of The Position: The Site Contracts Manager will support a global contracts and procurement function for a fast-growing CRO.  This position will negotiate and manage agreements for clinical research sites as well as sponsor and vendor agreements. 
• This position is primarily responsible for the preparation, negotiation, and finalization of study-level budget parameters and site-level budgets that are compliant with study protocol requirements and aligned with overall study budget projections to support clinical trials. In addition, this individual will support the larger Contracts and Legal Affairs department with the management and oversight of an assigned portfolio of agreements.
• This position is sponsor-facing.

Essential Functions:

Site Contracts:

• Responsible for the drafting, reviewing, negotiating, finalizing, and managing of site-related agreements including, but not limited to site confidentiality agreements (CDAs), clinical trial agreements (CTAs), master (template) site budgets, negotiated site budgets, letters of indemnification, site study start-up agreements, clinical trial agreement amendments, and termination agreements with limited support from department management.
• Manages assigned site contracting-related activities professionally, with careful compliance with internal processes and procedures, or otherwise according to specified customer requirements.
• Establishes pre-defined negotiation parameters for clinical trial agreement and site budget templates with the Sponsor before site selection. 
• Negotiates clinical trial agreement language and budgets with sites using pre-defined negotiation parameters.
• Collaborates with other departments involved in study start-up activities to ensure timely initiation of sites.
• Adequately advises the project manager and Sponsor of potential risks, benefits, and industry standards upon escalation of a clinical trial agreement or budget.
• Develops timelines with internal and external stakeholders for completion of the clinical trial agreement.
• Negotiates with the clinical study sites to reach a shared understanding of deliverables, a timely study start-up and financial obligations and supports management of sites to accurately project timelines, as well as expected processes and plans during active negotiation of a site clinical trial agreement and budget. 
• Attend and engage in scheduled project team meetings as needed.
• Maintains communication with sponsor and internal stakeholders regarding the status of all contractual requirements.
• Escalates issues appropriately to the Project Manager, legal, finance, or any other appropriate party.
• Proactively identifies site contract-related risks and potential roadblocks. Participates in project-related meetings as needed. Collaborates with the project team to ensure the sponsor's deliverables and expectations are achieved.
• Demonstrate a strong understanding of how the contracting and budget processes contribute to Project Management practices (schedule/cost forecasting and risk management).

Contracts & Procurement:

• This individual will support contracts & procurement-related activities with the negotiation, management and oversight of an assigned portfolio of sponsor, vendor, and other agreements.
• Sound business judgment is required; escalation of troublesome or unfamiliar contract/legal questions to senior management as appropriate. Communicates and explains legal/budgetary issues to internal and external parties per department guidelines.
• Ensures all contracts are completed and captured in FHIC’s internal tools and systems.
• Other ad hoc responsibilities may be required.

Knowledge, Skills, and Abilities:

• Extensive experience drafting, reviewing, and negotiating a wide range of agreements, both in the academic and private sectors. Ability to review, analyze, assess risk, and summarize findings for site contractual agreements.  Higher proficiency and confidence in operating within established operating procedures. Self-started and seeks minimal guidance and technical assistance from a supervisor, experts, and/or management.
• Exercises independent judgment in developing methods and techniques to obtain solutions (and process improvements). Independent in determining specific tasks to accomplish to meet certain goals and objectives. Self-reliant in performing tasks. Works independently.
• High level of attention to detail. Works on increasingly complex problems of diverse scopes requiring critical analysis and comprehensive evaluation of critical factors
• Effective/persuasive oral communication and business/technical writing skills. Proficient understanding of regulatory matters. Proficient in MS Office Products with advanced knowledge of Excel; ability to work with and be proficient in stand-alone system applications. Solid understanding of information systems.  Familiarity with Salesforce CRM, DocuSign, Costpoint & SharePoint preferred. Working knowledge of relevant business systems needed to support contract and procurement management activities.
• Ability to meet business-driven deadlines and commitments while maintaining a high level of quality, attention to detail, and professionalism.  Works in a team environment and interacts with internal and external clients at all levels of the organization.

Position Requirements:

Education:

• Bachelor’s degree or its international equivalent is required.
• A Masters’ or Professional Degree preferred, such as MBA, J.D., or the international equivalent.

Preferred Job-related Experience: 

• Five to seven years of (5-7 years’) experience required, with a minimum of three (3) years of experience in pharmaceuticals or a commercial CRO negotiating site contracts and site budgets.
• Two (2) or more years of experience in the management of contract agreements.

Preferences:

• Strong CRO/Pharma operational experience with a track record in Site Contracts Management working in an international or global capacity.
• Customer-focused and ability to manage challenging priorities and to remain flexible and adaptable in stressful situations.
• Understanding of clinical trial process across Phases I-IV and ICH GCP. Good understanding of clinical protocols and associated study specifications.
• Excellent understanding of clinical trial start-up processes.
• Quality-driven in all managed activities.
• Strong negotiating and problem-solving skills.
• Demonstrate an ability to provide quality feedback and guidance.
• Fluent knowledge of spoken and written English is required.

Physical Expectations:

• Typical office environment.
• Ability to sit or stand for extended periods.
• Ability to move 5-15 lbs.; or 2.26 - 6.8 kg.

Travel Requirements:

• Expected travel time is less than 10% for this position.