Job Information
Actalent Director Of Clinical Operations in Gaithersburg, Maryland
Director of Clinical Operations
Support the planning and implementation of clinical training, ensuring ongoing oversight and continuous
training throughout active clinical trials
Coordinate and manage all clinical operational activities across assignments
Lead and manage clinical operations staff, including external consultants and outsourced clinical research organization personnel responsible for clinical monitoring and data management of clinical trials
Ensure the delivery of high-quality operational results while maintaining consistency in processes and approaches
Assist in overseeing, drafting, and reviewing regulatory documents for submission to regulatory authorities, such as NDAs, INDs, annual reports, and responses to inquiries
from regulatory authorities and institutional review boards/ethics committees
Define and oversee clinical trial plans across a range of infectious disease target areas
Manage Contract Research Organizations (CROs) effectively to ensure that clinical studies are conducted to the highest quality standards, delivered on time, and within budget
Take responsibility for clinical project timelines and budgets
Facilitate the completion of study-specific procedures and plans generated by CROs, partners, etc.
Collaborate effectively with cross-functional teams to ensure the timely delivery of clinical trial materials to clinical sites and contribute to the development of procedures for
managing clinical samples for laboratory testing
Demonstrate a strong understanding of FDA and other regulatory authority requirements that impact clinical studies
Develop internal systems to ensure that clinical studies are conducted in compliance with current regulations and to prepare the company adequately for audits and inspections by government sponsors, FDA, and international regulatory authorities
Oversee the selection process for CROs, clinical trial sites, potential investigators, and external contractors
Monitor and evaluate clinical site performance as necessary
Ensure compliance with study plans through the review of data reports and outputs, including Key
Performance Indicators (KPIs), identified risks, and trends using outputs from monitoring activities and functional groups, as applicable
Additional duties
Qualifications
Postgraduate in life sciences with at least 15 + years of experience in clinical research roles (operational or quality), preferably including both CRO and sponsor company
experience
Experience in management and oversight of clinical studies at both early and late stage development
Experience in GCP compliance with a strong understanding of FDA regulations, EU Clinical Trials directive, and / SOPs in pharmaceutical or biotech environment required
Experience in establishing Risk Management plans and strategies per ICH GCP E6 (R2)
Experience in managing CROs, clinical study vendors, and consultants
Previous experience as a CRA and managing and leading CRA and monitoring activities
Complete knowledge of the drug development process and specific knowledge of clinical trial, clinical monitoring, and site management process, and associated industry regulations
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.