Director of Clinical Trials
- Posted: over a month ago
Lighthouse Lab Services is excited to represent a client that is rapidly growing in Secaucus, NJ- right outiside of Newark. They are in need of a Director of Clinical Trials to join their diverse team of innovative professionals!
Location: New Jersey, travel will be involved
Summary:Client is in the process of completing the project plan for the analytical and clinical activities required prior to 510(k) submission to the FDA. The successful candidate will also supervise various trials that are being conducted overseas.
The position requires the ability to coordinate the inputs and communicate effectively with the Head of Operations, Head of Regulatory and the Head of Clinical and Laboratory Affairs. DCT will coordinate input from them to generate protocol
development and associated documentation. The management of internal documentationResponsibilities:
- The DCT will be responsible for the creation, organization, execution, and
- completion of specific activities in this project which lead to successful
- submission to the FDA. These activities will include working cooperatively with
- Safeguard product development teams, Regulatory Affairs, Clinical and
- Laboratory Affairs and Client's contracted Clinical Research Organization.
- Responsibilities will include, but not limited to, setting deadlines,
- communicating with company executives about the state of the project,
- ensuring that activities stay on track and on budget. Ability to clearly justify
- any adjustments, if necessary, to meet new requirements. Development of
- the Project Plan will involve the definition of scope, schedule, finance, risk,
- quality and resource management.
- The DCT will also be responsible for non-regulatory trials designed to show
- clinical efficacy.
- The DCT will be prepared to work with operations in multiple time zones.
Skills and Qualifications:
Some of the skills include:
• Proven leadership skills in working with technical teams.
• Aptitude in clinical microbiology/infectious disease.
• Strong background in clinical diagnostics and molecular biology. Comfortable
with current terminology and practices
• Good communication and interpersonal proficiency, with good written skills.
• Cost and risk management experience.
• Detail-oriented and highly organized
• Hands-on approach, yet able to delegate effectively while maintaining
• Time management, meeting management, and multitasking skills.
• Friendly and approachable, able to listen to opinions and make sound
• Able to provide feedback, advice, project updates, and encouragement to team
• Sense of urgency – ability to prioritize workload effectively and motivated to
This position also requires the following qualifying experience:
• 3-5 years of experience in clinical trial project management in a Laboratory setting; Molecular
• Ability to analyze potential risks, issues, or changes to impact the project
timeline and to proactively address them
• Background in good documentation practices required for clinical trials.
• Experience in training of site personnel in SOP's and supervising compliance
with SOPs and regulations
• Knowledge of FDA regulations and their practical implementation.
• Proficiency in Microsoft Office Suite, and any project management software
• Bachelor's degree in business, management, or technical discipline
• Strong science background, specifically in microbiology/infectious diseases
- Monday- Friday; 8am-5pm
At Lighthouse Lab Services, we offer solutions to help start, grow, and run clinical laboratories. Our recruiting team has over 17 years of proven success placing job seekers in positions ranging from entry level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide, for permanent and travel positions with clients ranging from small hospitals to large reference laboratories.
It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Lighthouse Lab Services will provide reasonable accommodations for qualified individuals with disabilities.
Lighthouse Lab Services | 800-838-0602 | lighthouselabservices.com
#MTP Job ID: 15866
Lighthouse Lab Services
HealthcareView all jobs at Lighthouse Lab Services
What email should the hiring manager reach you at?