Clinical Trial Manager
- Support the implementation of clinical research studies within budget and on schedule
- Manage activities of Phase 1 and 2 clinical trial investigators with a focus on the US to ensure compliance with the study protocol and overall clinical objectives
- Coordinate and support study team meetings in collaboration with the Clinical Development, Clinical Operations, Data Management, Clinical Supply Chain. and Clinical Quality team
- Update the clinical team on timelines and milestones achieved for the study
- Manage and mitigate risks with the study team
- Provide Sponsor oversight of CROs and vendors in partnership with the rest of the Clinical Operations team to assure integrity of clinical data with respect to accuracy, accountability and documentation through review of case report forms, source documents, medical records, etc
- Perform clinical research site activities, such as onsite or remote monitoring, co-monitoring, and training visits, as needed
- Ensure that study documentation is maintained according to applicable regulations, industry-accepted standards, and SOPs that govern clinical studies both in the field and in-house
- Contribute to the development of study documentation, including protocol review, creating study operations manuals, ICFs, and designing CRFs
- Provide input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review, and report writing
- Collaborate with Clinical, Regulatory, and Quality team members to ensure compliance of department/study activities with FDA regulations, guidelines, and principles of ICH GCP and company SOPs
- Train team members, site staff, and vendors, as needed
- Limited travel possible to clinical sites to supervise and/or monitor clinical studies (:25%)
- Bachelor’s or Master’s degree in Life Sciences, Nursing, Pharmacy, or related field
- Minimum 3–5 years of experience in clinical operations in a biotech or pharmaceutical company (Industry Sponsor)
- Experience managing US clinical sites, including start-up activities and monitoring
- Experience in oncology (preferably in solid tumors) or nuclear medicine; radiopharmaceuticals a plus
- Experience overseeing CROs and vendors a plus
- Familiarity with clinical data review and data management processes
- Excellent communication, organizational, and leadership skills
- Ability to work independently and manage multiple priorities
- Excellent knowledge of GCP, ICH, and FDA regulations
Recommended Jobs
Loader Operator (Req #: 1319) (Amherst)
Peckham Industries Location: Amherst, MA Pay Range: $37.95 - $37.95 Salary Interval: Seasonal Description: Application Instructions About Us: Peckham Industri…
Exhibitor Services Associate
Job Title : Exhibitor Services Associate Department : Exhibitor Services Reports to : Director of Guest and Exhibitor Services FLSA : Non-Exempt Grade : B Summary The Exhibitor…
AWS AI Engineer
Kforce has a client in need of an AWS AI Engineer in Boston, MA. Responsibilities: * Lead AI engineering initiatives, owning end-to-end solution delivery * Promote technical integrity and transparenc…
Ops Supervisor $26HR to $34HR DOE + QTR Bonus (BOS)
ODORZX INC is seeking a highly motivated and experienced Operations Supervisor to join our dynamic team in the carwash/detailing industry. As the Operations Supervisor, you will play a pivotal role i…
Reverse Commute to Boston!
(Physician/MD qualifications required) * Our client seeks a Family Medicine physician * Enjoy a reverse commute to Boston as well as a weekend away to Cape Cod! * Oversee the center as well as trea…
Moving and Junk Removal Helper
Do you like working in a team that has each other's back, is always innovating and trying new things and thrives on being the absolute best? Then you will love being with College Hunks Hauling Junk &…
Senior Editor, Books
America’s Test Kitchen seeks a talented Senior Editor to join a team of passionate cooks, editors, and designers. This person will manage development of a variety of cookbook projects created in colla…
Commissioning Field Engineer II
FST Technical Services’ Commissioning (Cx) Division is recognized as one of the leading commissioning firms in the nation. We partner with clients to provide comprehensive quality assurance througho…
Customer Service Analyst
: Careers at MassHousing At MassHousing, we believe a home is more than a roof and four walls. A home is safety and security, opportunity and peace of mind. Our team of talented professionals w…
Senior Project Engineering Manager - Water/Wastewater
Why Black and Veatch Black & Veatch allows you to lend your talent and perspective to humanity’s biggest challenges in a flexible environment where you are empowered to grow and explore new possib…