Clinical Research Site Lead
4 weeks ago
Job Summary:
Parexel is seeking a Clinical Research Site Lead to join our team in the Northeast US or Florida. As a Site and Monitoring Health Lead, you will be responsible for ensuring the quality of clinical trial execution at investigator sites and overseeing the effectiveness of CRO monitoring.
Key Responsibilities:
- Implement various types of oversight encounters and activities, including site risk analysis, site contacts, and monitoring visit report review.
- Visit sites, conduct system/data spot checks, and provide periodic summaries to ensure timely documentation.
- Complete Sponsor Oversight Visit reports consistently on time and with good quality.
- Utilize a risk-based approach to review critical to quality items at the site level and study level.
- Create Study Specific Oversight Plans (SSOPs) for aligned trials in scope and/or follow SSOP when conducting oversight activities.
- Troubleshoot and use alternative and innovative approaches to solve problems impacting clinical site delivery and quality.
- Support inspection preparation and management.
Requirements:
- Significant direct monitoring experience gained with a CRO or pharmaceutical company working on multinational clinical studies.
- Lead CRA/management experience preferred.
- Experience in all study phases of clinical research (Phase I-III) and experience in both prevalent and rare medical conditions preferred.
- Previous audit and regulatory inspection experience preferred.
Education:
- Bachelor's Degree required.
- Clinical or advance degree (Registered Nurse (RN), Masters in Public Health (MPH), Masters of Science (MS), Masters of Arts (MA), Masters in Business Administration (MBA), Doctorate in Pharmacy (Pharm D) preferred.
Travel:
- 40-60% travel required.
EEO Disclaimer:
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
-
Senior Clinical Research Associate
2 weeks ago
Nagpur, Maharashtra, India Parexel Full timeUnlocking Clinical Trial SuccessThe Early Clinical Development Senior Clinical Research Associate will be responsible for conducting monitoring activities for multiple client-sponsored studies, adhering to Good Clinical Practices (GCP), International Conference on Harmonization (ICH), and client Standard Operating Procedures (SOPs).Key...
-
Senior Clinical Research Associate
2 weeks ago
Nagpur, Maharashtra, India Parexel Full timeParexel: Clinical Excellence in Early DevelopmentThe Senior Clinical Research Associate role is an integral part of our team, responsible for ensuring the highest standards of clinical excellence in early development. As a Senior CRA, you will conduct monitoring activities for client-sponsored studies, adhering to Good Clinical Practices (GCP), International...
-
Senior Clinical Research Project Manager
2 weeks ago
Nagpur, Maharashtra, India Parexel Full timeTransforming Clinical Research Projects into SuccessThe Global Project Leadership function at Parexel drives success for our clients and advances clinical research projects. As a key member of the Global Project Leadership organization, your work significantly impacts the projects, teams, and clients you interact with, helping to deliver projects that...
-
Project Lead in Biotech Clinical Trials
2 weeks ago
Nagpur, Maharashtra, India Parexel Full timeDriving Success in Biotech Clinical TrialsParexel's Project Leadership function is a critical part of driving success for our clients and advancing clinical research projects. As a Project Lead in Biotech Clinical Trials, your work will have a direct impact on the projects, teams, and clients you work with, while helping deliver projects to the benefit of...
-
Clinical Project Manager
2 weeks ago
Nagpur, Maharashtra, India Parexel Full timeParexel’s Project Leadership Team is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, helping to deliver projects to the benefit of the patients we serve.Parexel currently has...
-
Senior Clinical Trials Manager
3 weeks ago
Nagpur, Maharashtra, India Parexel Full timeVisionary Leadership in Clinical TrialsParexel seeks a seasoned Senior Clinical Trials Manager to drive success for our clients and advance clinical research projects. As a trusted member of the Global Project Leadership organization, you will play a pivotal role in delivering projects to the benefit of patients worldwide.With a strong background in clinical...
-
Enterprise Clinical Research Sales Director
3 weeks ago
Nagpur, Maharashtra, India Parexel Full timeUnlocking Business Growth and SuccessThe Enterprise Clinical Research Sales Director at Parexel is responsible for driving sales growth and profitability through strategic relationship-building with key accounts. This role supports the Account Leader in developing and executing account plans, financial metrics, and execution for a specific set of...
-
Project Manager
3 weeks ago
Nagpur, Maharashtra, India Parexel Full timeDrive Success in Clinical ResearchParexel's Project Leadership function is a critical component of delivering successful clinical research projects. As a Global Project Leadership professional, you will have a direct impact on projects, teams, and clients, while helping to advance clinical research projects to benefit patients.The Biotech Division at Parexel...
-
Global Clinical Trials Director
3 weeks ago
Nagpur, Maharashtra, India Parexel Full timeAt Parexel, our values of excellence, teamwork, and innovation drive us to achieve remarkable results. We're seeking a seasoned professional to join our Global Project Leadership team as a Project Director. This is a critical role in driving success for our clients and advancing clinical research projects. As a member of our team, your work will have a...
-
Dermatology Expertise in Clinical Research
3 weeks ago
Nagpur, Maharashtra, India Parexel Full timeAbout the RoleParexel is seeking a highly skilled Dermatologist to join our Medical and Sciences team. As an Associate/Medical Director, you will play a crucial role in providing medical monitoring for assigned projects and serving as a medical representative on the project team.Key ResponsibilitiesProvide medical expertise and leadership in Proposal...
-
Senior Clinical Project Manager – Biotech
2 weeks ago
Nagpur, Maharashtra, India Parexel Full timeUnlock Your Potential in Project LeadershipParexel's Global Project Leadership organization is seeking a skilled Senior Clinical Project Manager to drive success for our clients and advance clinical research projects in the biotech industry.As a member of our team, you will provide leadership to project teams, manage day-to-day operations, and strive to...
-
Nagpur, Maharashtra, India Parexel Full timeUnlocking Growth OpportunitiesThe Senior Account Director, Enterprise Clinical Research will be responsible for driving sales growth, profitability, and building relationships within a specific set of accounts. This role will support the Account Leader in developing, implementing, and achieving the business vision, strategy, plan, financial metrics, and...
-
Project Director
4 weeks ago
Nagpur, Maharashtra, India Parexel Full timeUnlock Your Potential in Clinical ResearchParexel's Biotech Division is seeking a seasoned Project Leadership professional to drive success for our clients and advance clinical research projects. As a critical part of our Global Project Leadership organization, your work will have a direct impact on projects, teams, and clients, while helping deliver...
-
Project Director
2 weeks ago
Nagpur, Maharashtra, India Parexel Full timeUnlock Your Potential as a Project DirectorParexel is seeking a highly skilled Project Director to lead our Clinical Trials team in the Biotech Division. As a senior member of our organization, you will be responsible for driving success for our clients and advancing clinical research projects.With a strong background in project management, you will provide...
-
Project Manager
2 weeks ago
Nagpur, Maharashtra, India Parexel Full timeDrive Success in Clinical ResearchThe Project Leadership function at Parexel plays a critical role in driving success for our clients and advancing clinical research projects. As a member of the Global Project Leadership organization, your work directly impacts projects, teams, and clients, while contributing to delivering projects that benefit...
-
Enterprise Clinical Research Sales Director
3 weeks ago
Nagpur, Maharashtra, India Parexel Full timeUnlocking Business PotentialThe Enterprise Clinical Research Sales Director is responsible for driving sales growth, profitability, and building relationships within a specific set of accounts. This role supports the Account Leader in developing, implementing, and achieving the business vision, strategy, plan, financial metrics, and execution for the...
-
Clinical Project Manager
3 days ago
Nagpur, Maharashtra, India Parexel Full timeJob OverviewParexel is seeking an experienced Clinical Project Manager to lead our Biotech division. This role will be responsible for managing global clinical trials, collaborating with cross-functional teams, and delivering projects on time, within budget, and to the highest quality.About UsParexel is a leading Contract Research Organization (CRO) that...
-
Senior Clinical Project Manager
4 weeks ago
Nagpur, Maharashtra, India Parexel Full timeDrive Success in Clinical ResearchParexel's Biotech Division offers a unique opportunity for seasoned Project Management professionals to lead global clinical trials in various therapeutics, including Neurology, Ophthalmology, Cardiology, Oncology, and Infectious Disease. As a Global Project Leadership Professional, you will provide leadership to project...
-
Project Director
3 weeks ago
Nagpur, Maharashtra, India Parexel Full timeUnlock Your Potential in Biotech Clinical TrialsParexel's Biotech Division is seeking a seasoned Project Leadership professional to drive success for our clients and advance clinical research projects. As a critical part of our Global Project Leadership organization, your work will have a direct impact on projects, teams, and clients, while helping deliver...
-
Clinical Operations Manager
4 weeks ago
Nagpur, Maharashtra, India Parexel Full timeParexel’s Clinical Operations Leader OpportunityParexel is seeking a skilled Clinical Operations Manager to join our team. As a key member of our Clinical Operations Leader team, you will be responsible for leading a team of professionals and ensuring the successful delivery of project deliverables.Key ResponsibilitiesLead a team of professionals and...