17 Director Of Clinical Operations Jobs in Gaithersburg, MD
Actalent is Hiring a Director Of Clinical Operations Near Gaithersburg, MD
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 for other accommodation options.
Job Summary
Full Time
$155k-214k (estimate)
06/14/2024
08/19/2024
The job skills required for Director Of Clinical Operations include Leadership, Clinical Operations, Initiative, Clinical Research, Clinical Trial, etc. Having related job skills and expertise will give you an advantage when applying to be a Director Of Clinical Operations. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Director Of Clinical Operations. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Director Of Clinical Operations positions, which can be used as a reference in future career path planning. As a Director Of Clinical Operations, it can be promoted into senior positions as a Critical Care Director that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Director Of Clinical Operations. You can explore the career advancement for a Director Of Clinical Operations below and select your interested title to get hiring information.
If you are interested in becoming a Director of Clinical Operations, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Director of Clinical Operations for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Director of Clinical Operations job description and responsibilities
This position will work collaboratively with the Vice President of Operations and the Medical Directors for each service line.
04/21/2022: Memphis, TN
The director provides oversight for all clinical processes to ensure efficiency and directs staff (either directly or through other managers/supervisors).
03/11/2022: Albuquerque, NM
This will have a primary focus of ensuring quality patient care and efficient clinic operations.
04/07/2022: Green Bay, WI
Behind the scenes of most large healthcare delivery systems stands a director of clinical operations.
05/29/2022: Augusta, GA
Clinical operations directors work with the goal of boosting economical and efficient performance of their medical team while delivering high-quality patient services.
04/13/2022: Norfolk, VA
Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Director of Clinical Operations jobs
A clinical operations manager oversees and directs the activities of a medical and healthcare facility.
04/16/2022: Durham, NC
Many employers prefer clinical operations manager candidates who have advanced degrees.
04/02/2022: Passaic, NJ
The Director must be disciplined about working with operations and strategy stakeholders to focus on highest value quick wins and be thoughtful about leveraging.
04/22/2022: Huntsville, AL
Additionally, all this work has to be done with rigor (no shortcuts) per country-specific Regulations and Good Clinical Practice.
03/18/2022: Springfield, OH
For a Director of Operations to excel, they should have full control over the organization’s processes.
04/16/2022: Phoenix, AZ
Step 3: View the best colleges and universities for Director of Clinical Operations.
