Senior Clincal Trial Associate
Genmab
Dato: for 19 timer siden
By: København, Region Hovedstaden
Kontrakttype: Entreprenør
At Genmab, we are dedicated to building extra[not]ordinary futures, together, by developing antibody products and groundbreaking, knock-your-socks-off KYSO antibody medicines that change lives and the future of cancer treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees.
Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.
Does this inspire you and feel like a fit? Then we would love to have you join us!
The Role
As Senior Clinical Trial Associate (Sr CTA) you play a key role in supporting Clinical Trial Team (CTT) and ensuring smooth trial operations. The Sr CTA assists with study documentation, regulatory compliance, communication between stakeholders, and overall trial coordination. This position is essential for maintaining high-quality clinical trial execution while ensuring adherence to Good Clinical Practice (GCP) guidelines and regulatory requirements. Our Sr CTA’s are expected to become Subject Matter Experts (SMEs) for assigned processes and systems.
The primary location for this role is Utrecht, The Netherlands. Candidates located in Denmark or the US are also welcome to apply.
Responsibilities
eTMF Management:
Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our 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 to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. 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 international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.
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 Job Applicant Privacy Notice (genmab.com).
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.
Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe that being proudly authentic and determined to be our best is essential to fulfilling our purpose. Yes, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.
Does this inspire you and feel like a fit? Then we would love to have you join us!
The Role
As Senior Clinical Trial Associate (Sr CTA) you play a key role in supporting Clinical Trial Team (CTT) and ensuring smooth trial operations. The Sr CTA assists with study documentation, regulatory compliance, communication between stakeholders, and overall trial coordination. This position is essential for maintaining high-quality clinical trial execution while ensuring adherence to Good Clinical Practice (GCP) guidelines and regulatory requirements. Our Sr CTA’s are expected to become Subject Matter Experts (SMEs) for assigned processes and systems.
The primary location for this role is Utrecht, The Netherlands. Candidates located in Denmark or the US are also welcome to apply.
Responsibilities
eTMF Management:
- Setup, maintain, oversee and close the Sponsor eTMF across trial, country and sites levels.
- Manage TMF health (completeness, quality and timeliness), including the monitoring of milestones relevant for the respective trial and the upload of documents as needed, etc.
- Ensure Audit/Inspection readiness by conducting regular eTMF health checks, including monthly eTMF reviews, bi-annual eTMF spot-checks, and milestone completion oversight, etc.
- Oversee and collaborate with the CRO on eTMF responsibilities (filing and TMF Health)
- Assist during Audits and Inspections in trial related tasks as required
- Schedule and coordinate meetings, taking minutes and following up on action items (meeting schedule and recording, meeting minutes preparation, meeting material filing in the eTMF, etc.)
- Coordinate logistics for key CTT meetings
- Participate in regular eTMF calls with the CRO TMF Lead to monitor eTMF status and follow up on open actions
- If applicable, provide Clinical Trial Governance (CT Gov.) site and status updates
- Organize and track clinical trial documentation and reports
- Assist in preparation of reports, presentations, and study-related materials
- Develop and maintain the study TMF Plan
- Support filing appendices of Clinical Study Report (CSR)
- Assume increased autonomy and responsibility for all assigned tasks
- Develop into a SME for assigned processes and systems.
- Assist in the development and editing of Sponsor materials (SOPs and Work Instructions (WI)
- Bachelor's or Master's degree in relevant technical area.
- Minimum requirement: 3-5 years in clinical trial operations.
- Experience in coordination and support activities for clinical trial conduct.
- Experience maintaining and tracking critical documentation.
- Excellent relational and communication skills in English.
- You are genuinely passionate about our purpose
- You bring precision and excellence to all that you do
- You believe in our rooted-in-science approach to problem-solving
- You are a generous collaborator who can work in teams with a broad spectrum of backgrounds
- You take pride in enabling the best work of others on the team
- You can 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!
Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance. Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our 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 to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and collaborative team has invented next-generation antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, next-generation immune checkpoint modulators and effector function-enhanced antibodies. 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 international presence across North America, Europe and Asia Pacific. For more information, please visit Genmab.com and follow us on LinkedIn and X.
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 Job Applicant Privacy Notice (genmab.com).
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.
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