- Drives site selection in collaborate with Start-up
- Review/approve SSV summary
- Coordinate the review of the CRO country-specific informed consent forms (ICFs) with internal stakeholder
- Coordinate translation/back translation process of ICFs
- Oversee vendor management across vendors (does not include budget/change orders)
- Approve key CRO staff e.g., Clinical leads, or Trial specific CRA (not including CRAs part of the partnership dedicated model which is managed via Oversight Manager)
- Conduct initial Protocol Deviation (PD) assessments and track trends
- Ensure the ongoing completeness of the electronic Trial Master File (eTMF)
- Keep the Trial Management Dashboard (TMD) and portfolio app in GenSense up to date
- Drive the ODB review meeting
- Participate in RBQM activities (as implemented going forward)
- Assist in maintenance of CTT issue log in collaboration with GCTM
- Collaborate or manage study escalations both internal & external
- Support GCTM to Assess KPI/KQI at the trial level
- Support QA in site audit activities and potentially vendor audits (supporting with trial information and collection and providing of relevant trial documents)
- Conduct booster visits
- Participate in inspection readiness activities as assigned
- Oversee and collaborate with CTT members/vendors/assigned functional representatives on tracking and reconciliation of trial related items such as scans, blood samples etc.
- Understanding of trial execution (knowledge of the processes, procedures, and principles involved in conduction clinical trials)
- Experience in clinical drug development & GCP
- Role model the Genmab ONE team spirit
- Excellent written and oral English communication skills
- Ability to proactively identify risks, develop mitigations, & resolve issues
- Stakeholder management both internal and external
- Ability to escalate issues as appropriate to internal or external stakeholders
- Experience with operating in a Global settings
- A BSc or MSc level within the medical, biological, pharmaceutical science or equivalent.
- Minimum 5 years' experience with clinical trial management from a pharmaceutical company and/or CRO.
- Experience within the field of oncology and/or first in human trials is preferred.
- Proven skills from working in a project oriented and international organization.
- Excellent communication skills in English both written and spoken.
- Dedicated team player who enjoys leading teams and inspire trust among colleagues.
- Quality mindset and able to prioritize your work in a fast paced and changing environment.
- Result- and goal-oriented and committed to contributing to the overall success of Genmab.
- 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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Senior Clinical Trial Manager - Princeton, United States - Genmab
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.
Senior Clinical Trial Manager
Are you looking for an opportunity where you can take the lead in delivering key trial management elements on oncology trials and ensure sponsor engagement? We a looking for a Senior Clinical Trial Manager driven by ensuring a one-team culture with CROs and who excels in contributing to great teamwork and working environment. Join our innovative, hardworking, and ambitious team collaborating in a high performing and high pace environment to improve the lives of cancer patients.
Working in Clinical Operations is exciting, intense, challenging, and fun at the same time. The dedication, collaborative and knock-your-socks-off spirit of our employees are what really shapes our team. From day one, the onboarding program makes sure that you accomplish trainings, get settled with our IT systems and that you team up with your mentor, colleagues, and relevant stakeholders.
Responsibilities
The Sr Clinical Trial Manager is accountable for delivery of selected and/or regional activities within a trial (e.g., manage and oversee vendor deliverables, collaborate with functions to set up activities [e.g. DM, IRT, eRT], support site activation and recruitment, support data review/cleaning activities, support PI/ICF development).
The principal responsibilities are:
·Develop operational plans, manuals and charters for the trial·Review protocol and protocol amendments and other trial documents as necessary·Create and coordinate the writing of Investigational Medicinal Product (IMP) Plan·Coordinate the development of the Trial Oversight Plan·Review the Clinical Trial Application (CTA) submission package·Review site regulatory documents·Develop Global Master ICF·Coordinate resolution of site or monitoring issues working with CRO or other applicable vendors
Site Selection and Management:
Vendor Management and Oversight:
Trial Execution and Monitoring:
Key Competencies
Requirements
Moreover, you meet the following personal requirements:
For US based candidates, the proposed salary band for this position is as follows:
$,.00---$,.00The 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
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.
