-
Clinical Trial Associate
4 days ago
UroGen Princeton, United States**Job Summary** · **Responsibilities**: · - Assist in study start up activities including collection and tracking of essential documentation needed for site initiation, maintenance and close out. · - Conduct ongoing maintenance of eTMF and quality checks through collaboration wit ...
-
Clinical Trial Associate
1 week ago
Novo Nordisk Plainsboro, United States**About the Department*** · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA ...
-
Associate Trial Attorney
3 weeks ago
Palmer & Barr, P.C. Philadelphia, United States**Palmer & Barr, a prominent insurance defense firm, has a tremendous opportunity available for an experienced attorney to join its growing team in Philadelphia. Hybrid position offers some remote opportunities.** · **Responsibilities**: · - **Case Management: Effectively manage ...
-
Clinical Trial Associate
5 days ago
Larimar Therapeutics Inc Bala-Cynwyd, United States: · **The Company**: · The company assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees. Their management team, employees, and consultants have significant expertise in discovery, nonclinical and ...
-
Msd Malaysia Trenton, United StatesClinical Trials Start-Up/Operations Associate page is loaded · Clinical Trials Start-Up/Operations Associate · Apply · remote type · Not Applicable · locations · AUS - New South Wales - Macquarie Park · time type · Full time · posted on · Posted Yesterday · job requisi ...
-
Senior Clinical Trial Drug Safety Associate I
3 weeks ago
Everest Clinical Research Trenton, United StatesSenior Clinical Trial Drug Safety Associate I · Job Category · : · Pharmacovigilance and Drug Safety · Everest Clinical Research ("Everest") is a full-service contract research organization (CRO) providing a broad range of expertise-based clinical research services to worldwid ...
-
Associate, Clinical Trials
1 week ago
Sun Pharmaceutical Industries Princeton, United StatesCOME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE · * Hybrid work arrangement · * Medical, Dental, Vision Benefits · * Health Savings Account (HSA), Flexible Spending Account (FSA) · * Prescription Drug Coverage · * Telehealth and Behavior Health Services · * Income Pr ...
-
Clinical Trial Associate
3 weeks ago
UroGen Princeton, United StatesJob Description · Job DescriptionSalary: $60K to $75K/Annual · Job Summary · The CTA will function in a key supporting role for the clinical team in all administrative aspects of the clinical projects assigned in accordance with GCP and regulatory authority guidance to ensure the ...
-
Clinical Trial Associate
3 weeks ago
Novo Nordisk A/S Plainsboro, United StatesTakes ownership to deliver upon near-term North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex cross-functional improvement/innovat Clinical, Management, Associa ...
-
Clinical Trial Associate
3 weeks ago
Pharmaron Newtown, United StatesJob Description · Job DescriptionJoin our dynamic team at Pharmaron where innovation meets excellence in clinical research. · As we continue to grow, we are seeking to add a skilled Clinical Trial Assistant to join our team and play a pivotal role in supporting critical projects ...
-
Clinical Trial Associate
3 weeks ago
BioSpace Plainsboro, United StatesJob Details · About the Department · The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From health-care-provider interactions and developing and implementing regulatory strategies wi ...
-
Clinical Trial Associate
1 week ago
Allen Spolden New Brunswick, United StatesJob Description · The remote-based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.Provide support for essential daily clinical ...
-
Clinical Trial Associate
4 days ago
Allen Spolden New Brunswick, United StatesJob DescriptionThe remote-based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.Provide support for essential daily clinical stu ...
-
Clinical Trial Associate
1 week ago
TFS HealthScience Cherry Hill, United StatesJob Description · Job Description***Recruiter PLEASE READ*** · We have provided you with a job advert framework to build on, please add the correct business area/line information, as well as the job title, responsibilities and requirements. · You should also select the appropria ...
-
Senior Clinical Trial Associate
3 weeks ago
GENMAB A/S Princeton, United StatesAt 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, ca ...
-
Personal Injury Trial Associate
1 week ago
PrideStaff Edison, United StatesWe represent a firm with a fulltime, direct hire Personal Injury Trial Associate opportunity in Edison, NJ. Salary: $80 - $100 k (depending on experience)Schedule: fully onsite Mon - Fri Personal Injury Trial Associate Requirements:1-3 years of pers Associate, Personal, Retail, S ...
-
Clinical Trial Associate II
1 week ago
Allen Spolden Raleigh, United StatesJob Description · The Office-Based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan. This is a position with a pharmaceutical com ...
-
Sr. Clinical Trial Associate
3 weeks ago
Allen Spolden New Brunswick, United StatesJob Description · The remote-based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.Provide support for essential daily clinical ...
-
Sr. Clinical Trial Associate
5 days ago
Allen Spolden New Brunswick, United StatesJob DescriptionThe remote-based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.Provide support for essential daily clinical stu ...
-
Clinical Trial Associate II
3 weeks ago
Allen Spolden New Brunswick, United StatesJob Description · The remote-based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.Provide support for essential daily clinical ...
Senior Clinical Trial Associate - Trenton, United States - Genmab A/S
Description
The Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at.
Senior Clinical Trial Associate page is loaded
Senior Clinical Trial Associate
Apply
locations
Utrecht
Princeton, NJ
Copenhagen
time type
Full time
posted on
Posted 2 Days Ago
job requisition id
R10719
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.
The Clinical Trial Associate (CTA) is responsible for overseeing filing of documents (eTMF) to ensure inspection readiness at trial level & supporting GCTM/CTM with key (administrative) activities.
Roles & ResponsibilitieseTMF Management:
Setup, maintain and close Sponsor eTMF (trial, country, sites, EDL, upload of document)
Oversight of eTMF (TMF-Browser, Monthly Review (Docs In Progress, EDL), eTMF Spot Check, review of classification as needed)
Audit/Inspection readiness preparation
Meeting and Communication Management:
Coordinate logistic for CTT meetings (emails in connection with the mtg, filing in eTMF, invites, recording)
Write CTT meeting minutes (guidance on how to take minutes during the CTT meeting is coming)
Coordinate logistics for Oversight Dashboard (ODB) Review meeting (run reports, invites, emails in connection with the mtg, filing in eTMF incl workflow)
Provide Clinical Trial Governance (CT Gov.) site and status updates
Plans and Resource Management:
Maintain CTT staff list in GenTrack/GenSense
Maintain Vendor list in GenTrack/GenSense
Setup and maintain CTT Charter
Support CTM in reviewing TMD and Portfolio App in GenSense
Provide input to Trial Oversight Plan
Provide input to TMF Plan
Clinical Study Report (CSR) Management:
Support filing appendices of Clinical Study Report (CSR)
Competencies
Planning and organization, multitasking
Clinical development experience
Process oriented
Communication skills – oral and written language skills
Problem-solving and critical thinking
Teamwork, vendor/stakeholder
collaboration/management
Adaptability to change of processes
Cultural awareness
Training and mentoring, continuous learning
Project and data/documentation management,
Maintain audit readiness, quality oriented
Level differentiation
Senior CTA
Assigned to complex trials preferable pivotal or phase III trials, trials within new indications etc.
SME for processes related to CTA 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 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
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.
About GenmabGenmab 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.
About UsGenmab 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.#J-18808-Ljbffr