Associate Director, Clinical Trial Associate

6 maanden geleden

Utrecht, Nederland Genmab Voltijd

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.

As a Clinical Trial Associate Team Manager (CTA TM) you will be in the Trial Strategy and Delivery department and responsible for managing a team of Clinical Trial Associates (CTAs).  You will report to the Head of Trial Management and work closely with the Global Clinical Trial Managers (GCTMs), Clinical Project Leads (CPLs) and other Clinical Trial Team (CTT) members.   

Key responsibilities include:

  • Leading and managing a team of CTAs
  • Supporting and providing direction to CTAs on their key responsibilities and activities
  • Allocating resources effectively to support ongoing and upcoming clinical trials
  • Developing comprehensive onboarding and training program to equip CTAs with the necessary knowledge and skills
  • Providing coaching and mentorship to CTAs to support their development and career progression
  • Monitoring and evaluating the performance of the entire CTA team, and implementing strategies to maintain consistency and uphold high standards across all CTAs
  • Leading or actively contributing to process improvement initiatives
  • Preparing and supporting CTAs for audits and inspections, and ensuring inspection readiness of clinical trial documentation
  • Creating a cohesive and positive work culture by fostering belonging, commitment, and open communication among CTAs

Requirements - what you must have

  • Bachelor’s Degree within life science or equivalent combination of education, training, and relevant experience
  • At least 8 years of relevant experience in the biotechnology/pharmaceutical, CRO, or healthcare industry
  • At least 2 years of management experience in industry settings, preferably in pharma/biotech industry
  • Experience managing teams in a supervisory/leadership capacity
  • Experience required in clinical trial administrative and support activities performed throughout all trial stages, including experience with  Electronic Trial Master File (eTMF) 
  • Prior experience as a team leader is preferred

Competencies

  • Leadership and people management skills
  • Set direction, inspire, and motivate CTA team
  • Recruit and efficiently allocate resources
  • Coach and mentor employees
  • Identify, develop, and deliver trainings
  • Effective communication, stakeholder management, time management and organizational skills
  • Understand clinical development including regulatory requirements and ICH-GCP
  • Understand key clinical trial documentation and TMF requirements
  • Veeva Vault eTMF and other document management systems skills

About You - additional qualities you bring to the table

  • 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

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.

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