Az állásajánlat leírása

Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients. 

 

The Role

 

Genmab is looking for a motivated Clinical Start-Up Lead to join the Global Clinical Operations team. The position can be based at our offices in Copenhagen, Denmark or Princeton, NJ USA.

 

Global Clinical Operations is part of the Clinical Development department which is responsible for managing clinical cancer trials from early First-in-Human (FIH) studies to late-stage trials.

As Start-Up Lead, you will be responsible for supporting the CTM with start-up activities for Phase I-III clinical trials and ensure knowledge is transferred between trials both within but also across projects to secure a successful and timely start-up.

 

As Clinical Start-up Lead, you will be reporting to the Associate Director, Team Lead, Start-Up and Trial Management, and join a trial management team of Clinical Trial Managers, Sponsor Oversight Leads, Start-Up Leads, and Clinical Trial Assistants in Copenhagen and Princeton.

 

This position can be based in Princeton, NJ USA; Copenhagen, Denmark; or Utrecht, The Netherlands.



Responsibilities

  • Site CDAs

  • Site contracts and budgets

  • Involved in PI/ICF master development

  • Review of country/site specific PI/ICFs and communication with the CROs Support activities in relation to IRB/EC/CEC submissions and questions

  • RGL review

  • Ensure collection of 1572 forms and reconciliation



Requirements

  • A minimum of 3-5 years of relevant experience in the biotechnology/pharmaceutical, CRO or healthcare industry

  • Bachelor’s Degree within life science or equivalent combination of education, training, and relevant experience

  • Experience in Clinical Operations and a thorough understanding of GCP, relevant ICH standards, and FDA/EMA guidelines would be beneficial

  • Experience in project management and either site contract or budget drafting, negotiation, and execution across Phase I-III clinical trials

  • Excellent communication (oral and written) and negotiation skills, including conflict resolution, decision making and presentation skills

  • Strong organizational skills, including the ability to prioritize and handle a high volume of tasks within a given timeframe

  • Proficient with both written and spoken English

 

 Moreover, you meet the following personal requirements:

  • You can work independently as well as in teams

  • You are capable of prioritizing work in a fast paced and ever-changing environment

  • You have a quality focus and an eye for detail

  • You are result and goal-oriented and committed to contributing to the overall success of Genmab

 

Genmab will offer the successful application a challenging position, where the right candidate will have the opportunity to work with highly specialised people across functions in an informal, multicultural environment, with an aim to make a difference in the lives of people with cancer.



At Genmab, we pride ourselves on our unique culture. We are committed to make a positive impact on the lives of cancer patients. We hypothesize and experiment to seek innovative solutions, no matter the employee’s role; we speak up, empower each other, and embrace change and growth; we respect and celebrate our differences while working as one team. Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. Genmab employees work with determination, challenge the status quo and cultivate a growth mindset in everything we do.

 

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.

 

Please note that if you are applying for a position in the Netherlands; Genmab’s policy for all permanently budgeted hires in this location 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.

 

Genmab A/S is committed to protecting your personal data and privacy. Please see our privacy policy for handling your data in connection with you application on our website https://www.genmab.com/privacy.

 

Scam alert

Please be alerted that at the moment a recruitment scam involving Genmab is circulating. The scam involves recruiters on LinkedIn and elsewhere, pretending to be Genmab employees, headhunting candidates, asking for CVs and other personal information. The scam can include asking for payment for interviews or interview preparation.  This communication is not coming from Genmab, we encourage people to stay alert and not to respond to these queries.

Állás részletei
Ágazat:
Scientific research and development
Foglalkozási terület:
Engineering professionals (excluding electrotechnology)
Education field:
Life sciences
Work experience:
Work experience is required
Munkatapasztalat időtartama:
Between 2 and 5 years
Bérsáv:
Not provided
Date of expiry:
Link for more information:
APPLY HERE

A vállalatról

ATTENTION: IF YOU WOULD LIKE TO APPLY TO ANY OF OUR AVAILABLE POSITIONS, PLEASE DO SO THROUGH THE LINK IN EACH VACANCY "LINK FOR MORE INFORMATION" "APPLY HERE"! WHO WE ARE Delivering on our promise for patients Founded in 1999 in Copenhagen, Denmark, we are a dual-listed, international biotechnology company specializing in the creation and development of differentiated antibody… További információ