Senior Clinical Trial Manager NJ

At Genmab, we’re committed to buildingextra not ordinary futures together, by developing antibodyproducts and pioneering, knock-your-socks-off therapies that changethe lives of patients and the future of cancer treatment andserious diseases.

From our people who are caring, candid, andimpact-driven to our business, which is innovative and rooted inscience, we believe that being proudly unique, determined to be ourbest, and authentic is essential to fulfilling our purpose.

SeniorClinical Trial Manager Are you looking for an opportunity where youcan take the lead in delivering key trial management elements ononcology trials and ensure sponsor engagement?

We a looking for aSenior Clinical Trial Manager driven by ensuring a one-team culturewith CROs and who excels in contributing to great teamwork andworking environment.

Join our innovative, hardworking, andambitious team collaborating in a high performing and high paceenvironment to improve the lives of cancer patients.

Working inClinical Operations is exciting, intense, challenging, and fun atthe same time. The dedication, collaborative andknock-your-socks-off spirit of our employees are what really shapesour team.

From day one, the onboarding program makes sure that youaccomplish trainings, get settled with our IT systems and that youteam up with your mentor, colleagues, and relevant stakeholders.

Responsibilities The Sr Clinical Trial Manager is accountable fordelivery of selected and / or regional activities within a trial(e.

g., manage and oversee vendor deliverables, collaborate withfunctions to set up activities e.g. DM, IRT, eRT , support siteactivation and recruitment, support data review / cleaningactivities, support PI / ICF development).

The principalresponsibilities are : ·Develop operational plans, manuals andcharters for the trial ·Review protocol and protocol amendments andother trial documents as necessary ·Create and coordinate thewriting of Investigational Medicinal Product (IMP) Plan ·Coordinatethe development of the Trial Oversight Plan ·Review the ClinicalTrial Application (CTA) submission package ·Review site regulatorydocuments ·Develop Global Master ICF ·Coordinate resolution of siteor monitoring issues working with CRO or other applicable vendorsSite Selection and Management : Drives site selection in collaboratewith Start-up Review / approve SSV summary Coordinate the review ofthe CRO country-specific informed consent forms (ICFs) withinternal stakeholder Coordinate translation / back translationprocess of ICFs Vendor Management and Oversight : Oversee vendormanagement 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 whichis managed via Oversight Manager) Trial Execution and Monitoring : Conduct initial Protocol Deviation (PD) assessments and tracktrends Ensure the ongoing completeness of the electronic TrialMaster File (eTMF) Keep the Trial Management Dashboard (TMD) andportfolio app in GenSense up to date Drive the ODB review meetingParticipate in RBQM activities (as implemented going forward)Assist in maintenance of CTT issue log in collaboration with GCTMCollaborate or manage study escalations both internal &external Support GCTM to Assess KPI / KQI at the trial level SupportQA in site audit activities and potentially vendor audits(supporting with trial information and collection and providing ofrelevant trial documents) Conduct booster visits Participate ininspection readiness activities as assigned Oversee and collaboratewith CTT members / vendors / assigned functional representatives ontracking and reconciliation of trial related items such as scans,blood samples etc.

Key Competencies Understanding of trialexecution (knowledge of the processes, procedures, and principlesinvolved in conduction clinical trials) Experience in clinical drugdevelopment & GCP Role model the Genmab ONE team spiritExcellent written and oral English communication skills Ability toproactively identify risks, develop mitigations, & resolveissues Stakeholder management both internal and external Ability toescalate issues as appropriate to internal or external stakeholdersExperience with operating in a Global settings Requirements A BScor MSc level within the medical, biological, pharmaceutical scienceor equivalent.

Minimum 5 years’ experience with clinical trialmanagement from a pharmaceutical company and / or CRO. Experiencewithin the field of oncology and / or first in human trials ispreferred.

Proven skills from working in a project oriented andinternational organization. Excellent communication skills inEnglish both written and spoken.

Moreover, you meet the followingpersonal requirements : Dedicated team player who enjoys leadingteams and inspire trust among colleagues.

Quality mindset and ableto prioritize your work in a fast paced and changing environment.Result- and goal-oriented and committed to contributing to theoverall success of Genmab.

For US based candidates, the proposedsalary band for this position is as follows : $114,375.00 $190,625.00The actual salary offer will carefullyconsider a wide range of factors, including your skills,qualifications, experience, and location.

Also, certain positionsare eligible for additional forms of compensation, such as bonuses.About You You are passionate about our purpose and genuinely careabout our mission to transform the lives of patients throughinnovative cancer treatment You bring rigor and excellence to allthat you do.

You are a fierce believer in our rooted-in-scienceapproach to problem-solving You are a generous collaborator who canwork in teams with diverse backgrounds You are determined to do andbe your best and take pride in enabling the best work of others onthe team You are not afraid to grapple with the unknown and beinnovative You have experience working in a fast-growing, dynamiccompany (or a strong desire to) You work hard and are not afraid tohave a little fun while you do so Locations Genmab leverages theeffectiveness of an agile working environment, when possible, forthe betterment of employee work-life balance.

Our offices aredesigned as open, community-based spaces that work to connectemployees while being immersed in our state-of-the-artlaboratories.

Whether you’re in one of our collaboratively designedoffice spaces or working remotely, we thrive on connecting witheach other to innovate.

About Genmab Genmab is an internationalbiotechnology company with a core purpose guiding its unstoppableteam to strive towards improving the lives of patients throughinnovative and differentiated antibody therapeutics.

For more than20 years, its passionate, innovative and collaborative team hasinvented next-generation antibody technology platforms andleveraged translational research and data sciences, which hasresulted in a proprietary pipeline including bispecific T-cellengagers, next-generation immune checkpoint modulators, effectorfunction enhanced antibodies and antibody-drug conjugates.

To helpdevelop and deliver novel antibody therapies to patients, Genmabhas formed 20+ strategic partnerships with biotechnology andpharmaceutical companies.

By 2030, Genmab’s vision is to transformthe lives of people with cancer and other serious diseases withKnock-Your-Socks-Off (KYSO™) antibody medicines.

Established in1999, Genmab is headquartered in Copenhagen, Denmark with locationsin Utrecht, the Netherlands, Princeton, New Jersey, U.

S. and Tokyo,Japan. Our commitment to diversity, equity, and inclusion We arecommitted to fostering workplace diversity at all levels of thecompany and we believe it is essential for our continued success.

No applicant shall be discriminated against or treated unfairlybecause of their race, color, religion, sex (including pregnancy,gender identity, and sexual orientation), national origin, age,disability, or genetic information.

Learn more about ourcommitments on our website. Genmab is committed to protecting yourpersonal data and privacy. Please see our privacy policy forhandling your data in connection with your application on ourwebsite https : / / www.

genmab.com / privacy. Please note that if you areapplying for a position in the Netherlands, Genmab’s policy for allpermanently budgeted hires in NL is initially to offer a fixed-termemployment contract for a year, if the employee performs well andif the business conditions do not change, renewal for an indefiniteterm may be considered after the fixed-term employmentcontract.