Summary of the position:

Responsible for setting the overall direction, strategy, and performance standards for Clinical Research activities (including the planning, execution, monitoring, and reporting of international clinical trials) within FHI Clinical Inc. Leads and mentors the clinical team, maintaining the appropriate resources to meet contractual obligations while ensuring adherence to quality management practices. Provides strategic direction ensuring that the organization and conduct of regulatory and non-regulatory clinical programs is in compliance with policies and procedures, Regulatory Authority requirements and guidelines, and International Conference on Harmonization (ICH) Guidelines in support of global business objectives. Sets the overall direction and strategic implementation of trial execution for investigational drugs and devices to document safety and efficacy, and ensure data integrity (in collaboration with other functional groups, e.g., data management and biostatistics). Provides oversight of a portfolio of trials to ensure high-quality services are delivered on time and within scope and budget.

Essential functions:

• Provides strategic leadership and oversight for FHI Clinical operations.
• Determines the overall direction, strategy and performance standards for the portfolio of clinical research projects conducted within FHI Clinical.
• Accountable for the successful delivery of FHI Clinical services in the implementation of clinical trials.
• Develops collaborative alliances and relationships with clients, investigators, and advisors.
• Provides Clinical Operations expertise and leadership to cross-functional project teams for assigned products and indications.
• Ensures that services provided to clients are compliant with FHI Clinical SOPs and FHI Clinical procedures, ICH-GCP and country-specific regulations as well as client contractual expectations.
• Accountable for the development of Clinical Research infrastructure in FHI Clinical (e.g., SOPs, WIs, Clinical Trial Management System, budget, and planning).
• Proactively projects resource needs to ensure appropriate staffing to meet client project objectives.
• Promotes a positive and professional work environment that attracts and retains the best talent and delivers services that exceed client expectations.
• Manages senior staff and oversees the management of other clinical operations staff, ensuring alignment with strategic and programmatic goals and that performance meets and exceeds both business and personal objectives.
• Oversees/participates in the implementation of sponsor and investigator meetings, conferences, and workshops.
• Provides key leadership and expertise in client presentations and bid defense meetings.
• Supports efforts for generating business leads (client networking, public speaking, etc.)
• Provides leadership to proposals for project bids to incorporate therapeutic area expertise and to ensure that projects can be successfully implemented.
• Engages in strategic planning activities and implements strategic decisions into operational plans for FHI Clinical.
• Provides strategic input into the planning and selecting sites and subject recruitment strategies.
• Monitors overall portfolio, key milestones, and deliverables; ensures consistent, accurate reporting to stakeholders as needed.
• Recognizes systemic issues at the portfolio level and identifies solutions with project teams or recommends actions to improve inefficiencies and oversees the implementation of best practices.
• Acts as the escalation point for any client or implementation-related issues within the portfolio; determines and executes resolution, working with FHI Clinical leadership as needed.
• Provides leadership in the development of new and improved processes related to trial planning, budgeting, control, and management.
• Supports performance management and professional development of direct reports, including ongoing feedback, coaching, and career support
• All other duties as assigned.

Knowledge, skills, and abilities:

• Proven ability to lead an international cross-functional clinical research team.
• Exhibits an open and constructive leadership style.
• Deep knowledge of clinical trial management techniques and tools.
• Extensive knowledge of global clinical trials management environment.
• Knowledgeable and experience with Clinical Trial Management Systems.
• Proven experience in trial management, risk mitigation and change management.
• Able to work closely with Finance Management to understand customer’s needs, study budgets and forecasting.
• Extensive knowledge of international clinical research regulatory guidance documents and regulations.
• Able to plan and organize efficiently by adhering to existing processes and procedures and by maximizing the use of available internal and external resources.
• Good computer skills including knowledge and experience of Microsoft Office applications.
• High degree of accuracy and attention to detail.
• Well-developed oral and written communication skills
• Proven ability to lead an international cross-functional clinical research team.
• Exhibits an open and constructive leadership style.
• Deep knowledge of clinical trial management techniques and tools.
• Extensive knowledge of global clinical trials management environment.
• Knowledgeable and experience with Clinical Trial Management Systems.
• Proven experience in trial management, risk mitigation and change management.
• Able to work closely with Finance Management to understand customer’s needs, study budgets and forecasting.
• Extensive knowledge of international clinical research regulatory guidance documents and regulations.
• Able to plan and organize efficiently by adhering to existing processes and procedures and by maximizing the use of available internal and external resources.
• Good computer skills including knowledge and experience of Microsoft Office applications.
• High degree of accuracy and attention to detail.
• Well-developed oral and written communication skills

Position Requirements

Education: Master’s Degree or its International Equivalent in Biology, Chemistry, Clinical Trials, Life Sciences or related field.

Preferred Job-related Experience: Requires 12+ years of experience in the area of clinical research, implementation, analysis and project management. Five (5) or more years of leadership and management experience, including multi-regional and global focus.

Additional Eligibility Qualifications: Prior experience in a non-governmental organization (NGO), government agency, or private organization.

Preferences: Relevant certifications in the area of clinical trials, and/or project management.

Source:https://fhi.wd1.myworkdayjobs.com/en-US/FHI_360_External_Career_Portal/job/USA-Any/Director--Clinical-Operations--FHI-Clinical-_Requisition-2021201113-1