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About the Role

The Site Activation Operations Director is responsible for supporting operational and financial delivery of end-to-end site activation. This includes leading and/or supporting resource management, start-up systems, quality management, process improvement, business and operational metrics, regulatory intelligence, and management of assigned Site Activation Assistants.

Responsibilities

• Support the identification, development, and adoption of best practices across the Site Activation team.
• Lead and/or support process improvement initiatives as the Site Activation business lead or representative.
• Support the identification, development, collation, and adoption of departmental business and operational metrics, including key performance indicators and key quality indicators.
• Liaise with Site Activation business owners to develop relevant metric dashboards.
• Support Quality Assurance activities, including the review and development of QMDs, coordinating Site Activation support of audits and inspections, coordinating response to QI, and serving as CAPA manager as appropriate.
• Represent the Site Activation department on relevant quality governance committees.
• Support the identification, development, implementation, deployment, and adoption of start-up systems.
• Serve as the business owner of key systems as requested.
• Support the identification, collation, and maintenance of clinical trial intelligence.
• Lead the Regulatory Intelligence Committee and supervise Regulatory Intelligence assessments and related implementations.
• Support sales activities, including development of proposal text, case studies, infographics, and PowerPoint slides.
• Represent the Site Activation department during general capability and bid defense meetings as needed.
• Implement the short-term and long-term objectives, major plans, and programs of the Site Activation division to ensure alignment with corporate strategy and objectives.
• Ensure authorized plans and programs for the global Site Activation division are properly implemented and that Executive Leadership is informed of overall trends and conditions impacting profitability, market position, or industry stature.
• Supervise the Site Activation Operations (SA Ops) Assistants team with the assistance of the Site Activation Operations Lead.
• Manage SA Ops resourcing to capacity, interview potential SA Ops assistants if necessary, write and conduct performance evaluations for direct reports, and ensure training and ongoing development of the SA Ops team.
• Assist with performance, site, and sponsor issues as needed.

Requirements

• Four-year college curriculum with a major concentration in biological, physical, health, pharmacy or other related science and six years clinical research experience as a clinical research associate OR
• Two-year college curriculum (unless nursing degree then see requirement above) or equivalent education/training and seven years clinical research experience as a clinical research associate OR
• Eight years of clinical research experience as a clinical research associate or other position directly related to clinical research with a CRO, pharmaceutical or biotechnology company.
• Travel required (passport required).

Skills

• Strong leadership skills
• Excellent planning, strategizing, managing, monitoring, scheduling, and critiquing skills
• Superior written and verbal communication skills
• Strong interpersonal skills
• Experienced problem solving/decision making skills
• Good attention to detail
• Understanding of clinical research principles and process
• Data collection and editing skills
• Strong knowledge of FDA regulations
• Strong knowledge of ICH Guidelines
• Understanding of standard operating procedures
• Knowledge of Word, Excel and Outlook

Location

• Global

Work Type

• Full-time

Experience Level

• 6+ years clinical research experience
• 7+ years clinical research experience
• 8+ years clinical research experience

Education Level

• Four-year college curriculum in a related science
• Two-year college curriculum or equivalent education/training
• Nursing degree

About the Company

• Worldwide Clinical Trials is a global, midsize CRO that pushes boundaries, innovates, and invents.
• The company has over 3,500+ experts worldwide.
• Their mission is to work with passion and purpose every day to improve lives.
• They believe everyone plays an important role in making a world of difference for patients and their caregivers.
• They prioritize cultivating a diverse and inclusive environment that promotes collaboration and creativity.
• They are committed to enabling professionals from all backgrounds and experiences to succeed.
• They are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.

Equal Opportunity

• Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed.
• They prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity.
• They provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.