Clinical Trial Assistant (Hybrid)

2024-04-09 | Genmab | Princeton | New Jersey | United States

Perks & Benefits:

Location:
777 Scudders Mill Rd, Princeton, NJ 08540
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 lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in science, we believe that being proudly unique, determined to be our best, and authentic is essential to fulfilling our purpose.
The Role & Department
The Clinical Trial Assistant (CTA) is responsible for filing of documents (eTMF) to ensure inspection readiness at trial level as directed, by supporting Global Clinical Trial Management (GCTM)/Clinical Trial Management (CTM) & supporting GCTM/CTM in Development Operations with administrative activities.
Working in Development Operations is exciting, challenging, and fun at the same time. The dedication, collaborative and knock-your-socks-off spirit of our employees are what really shapes our team. From Day One, the onboarding program makes sure that you accomplish trainings, get settled with our IT systems, and team up with your mentor, colleagues, and relevant stakeholders.
Key responsibilities
eTMF Management:
  • 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.
Meeting and Communication Management:
  • 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.
Plans and Resource Management:
  • 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.
Other core activities:
  • 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.
Requirements – what you must have
  • 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.
Where you will work
This role is based in Genmab’s office in Princeton, NJ USA and is hybrid.
For US based candidates, the proposed salary band for this position is as follows:
$48,750.00-$81,250.00
The actual salary offer will carefully consider a wide range of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as bonuses.
About You
  • 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
Locations
Genmab leverages the effectiveness of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are designed as open, community-based spaces that work to connect employees while being immersed in our state-of-the-art laboratories. Whether you’re in one of our collaboratively designed office spaces or working remotely, we thrive on connecting with each other to innovate.
About Genmab
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030, Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
Our commitment to diversity, equity, and inclusion
We are committed to fostering workplace diversity at all levels of the company and we believe it is essential for our continued success. No applicant shall be discriminated against or treated unfairly because of their race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, or genetic information. Learn more about our commitments on
our website
.
Genmab is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with your application on our website
https://www.genmab.com/privacy
.
Please note that if you are applying for a position in the Netherlands, Genmab’s policy for all permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs well and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.

Find out more jobs in Princeton, New Jersey (NJ), United States (US)

6 Jobs Found

Electrical Manufacturing Technician III

Collins Aerospace

2024-07-15330 Carter Road, Princeton, NJ 08540

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

2024-07-14Princeton, NJ

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

2024-05-22Princeton, NJ

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

2024-04-09777 Scudders Mill Rd, Princeton, NJ 08540

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

2024-04-08Princeton, NJ

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

2024-03-281 Bayard Lane, Princeton, NJ 08540

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...