Clinical Trial Assistant (Hybrid)
Perks & Benefits:
- Setup, maintain and close Sponsor eTMF (trial, country, sites, EDL, upload of document).
- Proactive review of eTMF (TMF-Browser, Monthly Review (Docs In Progress, EDL), eTMF Spot Check, review of classification as needed).
- Support, as needed, to resolve any inconsistencies identified during routine checks and filing.
- Audit/Inspection readiness preparation.
- Coordinate logistics for internal and external meetings, including but not limited to the Clinical Trial Team (CTT) meetings (emails in connection with the mtg, filing in eTMF, invites, recording, etc.).
- Prepare agendas and write meeting minutes.
- Coordinate logistics for Oversight Dashboard (ODB) Review meeting (run reports, invites, emails in connection with the mtg, filing in eTMF incl workflow).
- Provide Clinical Trial Governance (https://clinicaltrails.gov) site and status updates.
- Support QC and development of graphical presentations, etc.
- Maintain CTT staff list in GenTrack/GenSense.
- Maintain Vendor list in GenTrack/GenSense.
- Setup and maintain CTT Charter.
- Support CTM in reviewing TMD and Portfolio App in GenSense.
- Provide input to Trial Oversight Plan.
- Provide input to TMF Plan.
- Support handling of site contracts, ongoing updates of the trial dashboard, trial budget maintenance and development.
- Support filing appendices of Clinical Study Report (CSR).
- Support inspection preparations.
- Completed high school diploma or equivalent education.
- Some experience in administration, customer service, or related field preferred.
- Demonstrated proficiency in written and oral English communication.
- Experience of working with tools like Microsoft Office, Microsoft Teams, SharePoint, etc. and experienced in using IT systems.
- Well-organized and structured, with a sense of attention to detail.
- Can work in an environment with many competing priorities.
- Service mindset.
- Able to work independently as well as in global teams.
- Quality mindset and can prioritize your work in a fast paced and changing environment.
- Results- and goal-orientation and committed to contributing to the overall success of Genmab.
- You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment
- You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving
- You are a generous collaborator who can work in teams with diverse backgrounds
- You are determined to do and be your best and take pride in enabling the best work of others on the team
- You are not afraid to grapple with the unknown and be innovative
- You have experience working in a fast-growing, dynamic company (or a strong desire to)
- You work hard and are not afraid to have a little fun while you do so
Find out more jobs in Princeton, New Jersey (NJ), United States (US)
Electrical Manufacturing Technician III
Collins Aerospace
Date Posted: 2024-03-18 Country: United States of America Location: HNJ03: ISR Systems - Princeton 330 Carter Road, Princeton, NJ, 08540 USA Position Role Type: Onsite ...
Medicaid Policy Advisory Services Analyst
Mathematica Policy Research
Position Description: Mathematica applies expertise at the intersection of data, methods, policy, and practice to improve well-being around the world. We collaborate close...
Home SSI GCB
DSM
Home Segment Strategy and Innovation - Global Consumer Brands (GCB) Princeton, USA On Site Join our team as a Home Segment Strategy and Innovation leader for Global Consumer...
Clinical Trial Assistant (Hybrid)
Genmab
At Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the ...
Sales Associate
LINDT & SPRUNGLI
Position Purpose Do you LOVE and appreciate premium chocolate? Do you consider yourself a chocolate enthusiast? As a Chocolate Advisor at Lindt USA, you will be joining...
HOUSEKEEPER (PART TIME)
Compass Group USA
We have an opening for a part time HOUSEKEEPER position. Location: Palmer House - 1 Bayard Lane, Princeton, NJ 08542. Note: online applications accepted only. Schedule: P...