Regional Sponsor Oversight Lead
hace 5 días
Genmab is focused on the creation and development of innovative and differentiated antibody products, with the aim of improving the lives of cancer patients.
- Regional Sponsor Oversight Lead
The Role
The Regional Sponsor Oversight Lead (RSOL) will drive on site and remote Oversight activities across all trials/countries/sites within a region to support trial teams. The regional SOL will work closely together with the Clinical CRO in the countries/regions where the employee is performing sponsor oversight to get in depth local knowledge on local requirements to support efficient conduct of Genmab clinical trials.
**Responsibilities**:
The responsibilities of the role will include, but are not limited to:
Attend PSSV and SIV to support trial start up activities, as applicable;-
- Support onsite and remote oversight activities regionally;-
- Support audit and site inspection activities in close collaboration with the Genmab trial teams and the QA department;-
- Support development of mitigation plans and give input to the Trial Specific Oversight plan;-
- Review of monitoring reports;-
- Plan and perform Sponsor oversight visits and booster/site oversight visits-
- Support eTMF review;-
- Support other Genmab SOL activities such as training of clinical CRO in accordance to the trial Oversight plan across trials;-
- Assist/give input in trials teams to the trial “issue log”.**Requirements**:
It is expected that you have a minimum of 2 years' experience with monitoring and/or co-monitoring of clinical trials (Phase I experience preferred);-
- Preferably 3 years’ experience as Trial Manager or Lead CRA from a CRO and/or pharmaceutical company;-
- Extensive knowledge of working with trial oversight activities is requiredMoreover, you meet the following personal requirements:
You are structured and process oriented;-
- You have a quality mindset and able to prioritize your work in a fast paced and changing environment;-
- You have good interpersonal and communication skills during interactions with investigators and other external and internal stakeholders;-
- You are able to work independently as well as within global teams;-
- You are result
- and goal-oriented and committed to contributing to the overall success of Genmab.At Genmab, we pride ourselves on our unique culture. We are committed to make a positive impact on the lives of cancer patients. We hypothesize and experiment to seek innovative solutions, no matter the employee’s role; we speak up, empower each other, and embrace change and growth; we respect and celebrate our differences while working as one team. Teamwork and respect are central pillars of Genmab’s culture and we therefore ensure an inclusive, open, and supportive professional work environment across our international locations. Genmab employees work with determination, challenge the status quo and cultivate a growth mindset in everything we do.
Scam alert
-
Quality Manager
hace 7 días
En remoto, España IQVIA A tiempo completoJob Overview This role is an individual contributor assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the line manager (LM). The purpose of this role is to work together with global or regional Quality Management team(s), functional teams, and other stakeholders in a joint effort to clearly define the...
-
Cpm or Srcpm Emea, Sponsor Dedicated, Home-based
hace 2 semanas
En remoto, España IQVIA A tiempo completo**Join us in our exciting journey!!** **IQVIA is expanding in EMEA!! **We currently have a Regional CPM **to work sponsor-dedicated** to one of our pharmaceutical clients The Senior Project Lead is an ess**ential member of the core project** team leading the team and responsible for project delivery of clinical studies to meet contractual requirements in...
-
Senior Safety Project Lead
hace 2 semanas
En remoto, España IQVIA A tiempo completo**Senior Safety Project Lead** will be responsible for management and service delivery excellence for assigned projects, covering post-market products. You will provide leadership and accountability for customer-facing activities and oversight of operational service delivery, working cross-functionally and across the opportunity lifecycle, integrating...
-
Director Regional Sales
hace 1 semana
remoto, España Medium A tiempo completoThis position is posted by Jobgether on behalf of a partner company. We are currently looking for a Director Regional Sales in Spain . In this role, you will lead and grow a high-performing sales organization across multiple countries in the MED region, including Israel, Turkey, the Balkans, and Malta. You will be responsible for shaping regional...
-
Regional Sales Manager, Portugal
hace 7 días
En remoto, España CrowdStrike A tiempo completo#WeAreCrowdStrike and our mission is to stop breaches. As a global leader in cybersecurity, our team changed the game. Since our inception, our market leading cloud-native platform has offered unparalleled protection against the most sophisticated cyberattacks. We’re looking for people with limitless passion, a relentless focus on innovation and a...
-
Site Activation Manager
hace 2 semanas
En remoto, España IQVIA A tiempo completoProject manager for the start-up phase in charge of design and implementation of the strategy towards site activation from award until open to enrollment. Lead and oversee the country operations teams ensuring client commitments are delivered timely and according to project scope and processes. Direct and manage the delivery of all required site activation,...
-
Cloud Partner Sales Lead
hace 2 semanas
En remoto, España Cloudera A tiempo completoBusiness Area:SalesSeniority Level:DirectorJob Description:At Cloudera, we empower people to transform complex data into clear and actionable insights. With as much data under management as the hyperscalers, we're the preferred data partner for the top companies in almost every industry. Powered by the relentless innovation of the open source community,...
-
Clinical Trial Leader
hace 7 horas
En remoto, España Parexel A tiempo completoSpain, Remote **Job ID** R0000019423 **Category** Clinical Trials **ABOUT THIS ROLE**: **Role Purpose** The CTL provides leadership and direction to the trial team and is accountable for the overall success and delivery of their assigned clinical trial according to defined milestones and KPI’s. They are responsible for steering and directing clinical...
-
Senior Global Trial Manager
hace 7 días
En remoto, España Parexel A tiempo completoWorking as a Senior Global Trial Manager at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global Biotechs and Pharma top 50, and we have an incredible pipeline of work. Whether you see your future path in project management or other positions, we have a world of...
-
Clinical Lead Iii
hace 5 días
En remoto, España Premier Research A tiempo completoAt **Premier Research,** we help biotech and specialty pharma companies transform life-changing ideas into reality. What we do is profoundly connected to saving and improving lives, and we recognize our staff members are the most valuable asset in delivering success. Inspiring and nurturing staff to do their best work means a better, healthier future for...