Associate Director Global Clinical Trial Management
Associate Director Global Clinical Trial Management
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Salary Not Disclosed
1 Vacancy
Job Description
At Genmab were committed to building extranotordinary futures together by developing antibody products and pioneering knockyoursocksoff therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring candid and impactdriven 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
The Global Clinical Trial Manager (GCTM) is accountable for the endtoend delivery of a single or multiple clinical trials from strategy outline through to CSR by leading crossfunctional trial specific Clinical Trial Teams (CTT) to deliver clinical trials including managing the trial budget. The GCTM is accountable for trial deliverables and acts as point person for coordination of the TM team. The GCTM can at all times take the responsibilities of a CTM. If no CTM resource is assigned to a trial the GCTM takes on the CTM role too.
Responsibilities
- Lead the Clinical Trial Team (CTT) and Trial Management (TM) team
- Define and align CTT goals collaboratively with the team
- Review and approve protocol and amendment changes
- Review the Master Informed Consent Form (ICF)
- Approve operational plans manuals and charters for the trial
- Oversee the vendor selection process
- Initiate and verify the accuracy and completeness of initial Work Orders (WO) and Change Orders (CO)
- Guide the country selection process
- Coordinate responses to IEC/IRB comments
- Monitor major protocol deviations (PDs) and trends
- Approve data cleaning plans
- Collaborate with CPL as needed for CST/CDT
- Establish and maintain clear responsibility distribution
- Review and contribute to the CSR as needed
- Escalate issues to CPL in a timely manner
- Execute operational strategies related to drug supply regulatory submissions and recruitment
Budget and Planning
- Assist in the initial development and management of the trial budget
- Plan implement and maintain detailed integrated trial timelines from the study outline through CSR
- Develop initial recruitment projections and strategy
- Approve updated recruitment projections in alignment with CPL
- Serve as the counterpart for CRO PL/PM approving the CV of PL/PM
Risk Management
- Identify study risks with the CTT and oversee risk management activities
- Maintain and oversee the CTT issue log and ensure timely issue resolution
- Ensure CTT action and decision logs are uptodate
- Support audit preparation and responses
- Implement Corrective and Preventive Actions (CAPAs) if applicable
Requirements
- Bachelors or Masters degree with relevant specialization; Masters degree preferred
- Minimum requirement: 5 yearsin clinical operations
- Significant experience leading clinical projects
- Experience managing/guiding internal (crossfunctional) and external (CRO regulatory authorities) teams
- Some experience with operational management and budget planning
- Proven performance in earlier role/comparable role
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 rootedinscience approach to problemsolving
- 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 fastgrowing 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 worklife balance. Our offices are designed as open communitybased spaces that work to connect employees while being immersed in our stateoftheart laboratories. Whether youre 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 nextgeneration antibody technology platforms and leveraged translational research and data sciences which has resulted in a proprietary pipeline including bispecific Tcell engagers nextgeneration immune checkpoint modulators effector function enhanced antibodies and antibodydrug conjugates. To help develop and deliver novel antibody therapies to patients Genmab has formed 20 strategic partnerships with biotechnology and pharmaceutical companies. By 2030 Genmabs vision is to transform the lives of people with cancer and other serious diseases with KnockYourSocksOff (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 Job Applicant Privacy Notice (genmab).
Please note that if you are applying for a position in the Netherlands Genmabs policy for all permanently budgeted hires in NL is initially to offer a fixedterm 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 fixedterm employment contract.
Required Experience:
Exec
Employment Type
Full-Time
