- Lead the Clinical Trial Team (CTT)
- Lead the Trial Management (TM) team
- Define and manage CTT goals (together with CTT)
- Review and approve protocol and amendment changes
- Review Master ICF
- Approve operational plans, manuals and charters for the trial
- Oversee vendor selection process
- Initiate and ensure the accuracy and completeness of initial Work Order (WO) / Change Orders (CO)
- Drive country selection process
- Coordinate and respond to IEC/IRB comments
- Overview of major PDs and PD trending.
- Approve data cleaning plans
- Work closely with CPL as needed for CST/CDT
- Ensure responsibility split is developed and maintained
- Review and contribute to CSR as needed
- Escalate issues to CPL in a timely manner
- Execute operational strategy related to Drug supply
- Execute regulatory submission strategy
- Execute recruitment strategy
- Assist in initial development and Manage trial budget
- Plan, implement & ensure maintenance detailed integrated trial timelines from study outline though CSR (Gap: GCTM/CPL need a planner, e.g., MS Project, to show end to end project timelines and to build trust in organization).
- Develop initial recruitment projections and strategy
- Approve re-baseline recruitment projections in alignment with CPL.
- Act as counterpart for CRO PL/PM and approve CV of PL/PM
- Conduct study risks identification with CTT & risks management activities
- Oversee CTT issue log and issue resolution
- Oversee CTT Action/Decision logs are maintained
- Assist in preparation for & responses to audits
- Ensure CAPAs are in place, if applicable
- Demonstrated ability to lead & collaborate with cross-functional teams to drive operational excellence
- Experience in leading & managing global teams
- Experience in mentoring CTMs and CTAs
- Planning and budget management skills
- Outsourcing and vendor management experience
- Ability to anticipate risks and issues with proactivity to offer solutions & to timely escalate issues when needed
- Ability to foster a "One Team" spirit, inclusive mindset
- Confidence to challenging status-quo thinking and behavior; can work with agility and an innovative mindset
- Ability to align with Corporate, Dev Ops, Trial Management, and CDT goals
- Excellent written and oral communication skills
- Oncology experience strongly recommended
- 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
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Associate Director, Global Clinical Trial Manager - Princeton, United States - GENMAB A/S
Description
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.
Overview
The Global Clinical Trial Manager (GCTM) is accountable for the end-to-end delivery of a single or multiple clinical trials from strategy outline through to CSR by leading cross-functional trial specific Clinical Trial Teams (CTT) to deliver clinical trials including managing the trial budget.
Roles & Responsibilities
Trial Leadership and Management:
Budget and Planning:
Risk management:
$142, $237,500.00
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
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
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.
