Regulatory and Start Up Line Manager
4 weeks ago
Job Overview
Manages a single department or work unit responsible for site activation. Sets goals and objectives for team members for achievement of short-term operational or tactical results. Must have former people management experience.
Essential Functions
Manages staff's delivery of site activation activities in accordance with organization’s policies and applicable regulations. Responsibilities include planning, assigning, and directing work, assessing performance, and guiding professional development, rewarding and disciplining employee, and addressing employee relations issues and resolving problems.
Participate in the selection process for hiring new employees by conducting candidate review and participating in the interviewing process. Ensure that new employees are properly onboarded and trained.
Ensure that staff has the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan, SOP review and training experiences, as applicable.
Participate, as required, in the allocation of resources to clinical research projects by assigning staff based on their experience and training.
Manage the quality of assigned staff's work through regular review and evaluation of work product.
Identifies quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff.
Ensures that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management.
Responsible for leading moderate improvements of processes, systems or products to enhance performance of the job area.
Problems faced are difficult and may require understanding of broader set of issues.
Understands and demonstrates management approaches such as work scheduling, prioritizing, coaching and process execution.
Good knowledge and ability to apply GCP/ICH and applicable regulatory guidelines and applicable regulatory guidelines.
Qualifications
Bachelor's Degree Scientific discipline or health care preferred. Pref Typically requires a minimum of 3 -7 years of prior relevant experience. Specific requirements may be further defined by function.IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. Learn more at
-
Regulatory and Start Up Specialist 2
2 weeks ago
Oslo, Norway IQVIA Full timeJob Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. At least 3 years' experience with submissions and...
-
Oslo, Norway IQVIA Full timePrepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for complex projects and programs RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on complex clinical trial projects or programs and may act as a Regulatory Oversight for a key customer Ability to...
-
Oslo, Norway IQVIA Full timePrepares and/or reviews regulatory documents to support clinical trial submissions. Independently provides regulatory support for more complex projects. RESPONSIBILITIES Acts as a Clinical Trial Regulatory Manager (CTRM) on global projects which may be complex Ability to administratively and technically/scientifically review core scientific...
-
Experienced Clinical Research Associate
1 month ago
Oslo, Norway IQVIA Full timeJob Overview Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements. Essential Functions • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in...
-
Regulatory Compliance Specialist
4 weeks ago
Oslo, Norway CAE Inc Full timeRole and Responsibilities CAE is a high-technology company, bringing the digital and physical worlds closer together to create a safer world. Our vision is to be the worldwide partner of choice in civil aviation, defence and security, by revolutionizing our customers’ training and critical operations with digitally immersive solutions to elevate...
-
Project Manager
4 weeks ago
Oslo, Norway Elopak Full timeCome and join our team as a Project Manager for filling line installations. As a Project Manager you are responsible for each step of the process for the installations of the filling machines of the Elopak portfolio and also for the necessary other equipment. During the Pre Sales step your are involved in the customer discussions together with the...
-
Site Activation Specialist
3 days ago
Oslo, Norway IQVIA Full timeJob Overview Under moderate supervision, executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements at the regional, or country level. Prepares and manages site documentation; reviews and negotiates site documents and contracts with sites and sponsors;...
-
Head of Privileged Access Management
4 weeks ago
Oslo, Norway Nordea Bank Full timeJob ID: 22646 We are looking for an engaging Leader with a passion for Privileged Access Management (PAM) and development to lead a team of dedicated IT Security specialists and developers in our Identity and Access Management (IAM) organisation. This is an opportunity for you to be part of an international team, eager to support our mission to...
-
Senior Manager- Front Office
4 weeks ago
Oslo, Norway Statkraft Full timeCompany Description As part of the Norwegian state owned Statkraft Group, Statkraft Markets Pvt. Ltd. has been in India since 2012. Statkraft is one of the largest traders in the European energy market and an important actor internationally. We trade energy and commodities in more than 20 countries and are active on 13 energy exchanges. Statkraft...
-
Oslo, Norway Nordea Bank Full timeJob ID: 23913 We are looking for a Head of Personal Banking Data Privacy Risk Management to play a vital role in managing data privacy risks (including GDPR) towards our customers. This is an opportunity for you to grow and be part of an interesting journey within the data protection risk area. At Nordea, we see the world is changing fast – and...
-
Enterprise Sales Manager
1 month ago
Oslo, Norway Wolt Full timeAre you an experienced sales professional thats hungry for your next big challenge? Do you have a strong understanding of retail operations in Norway? If this sounds like you, then wed love to chat! So we have built this rocketship. We call it Wolt. And were on a mission to make cities a better place to live with the help of technology. Our local commerce...
-
Risk Expert/Senior Risk Expert
16 hours ago
Oslo, Norway Nordea Bank Full timeJob ID: 24358 Nordea is growing in Norway and we are looking for credit risk experts who wish to make a difference and develop Nordea’s credit risk framework and processes for our retail customers and credit automation. Do you have experience in handling household customers and are you interested in further developing Nordea’s risk management...
-
Finance Line of Business Director
2 weeks ago
Oslo, Norway NTT DATA Full timeJob Description Finance Line of Business Director i NTT Data Business Solutions – en SAP Platinum-partner!NTT DATA ekspanderer og fortsetter å vinne nye SAP-prosjekter i det norske markedet. Hos NTT DATA Business Solutions tilbyr vi et sosialt arbeidsmiljø, i en internasjonal virksomhet. Vi har fokus på kompetanseutvikling, og drives alle mot et felles...
-
Finance Line of Business Director
4 weeks ago
Oslo, Norway NTT DATA Full timeFinance Line of Business Director i NTT Data Business Solutions – en SAP Platinum-partner! NTT DATA ekspanderer og fortsetter å vinne nye SAP-prosjekter i det norske markedet. Hos NTT DATA Business Solutions tilbyr vi et sosialt arbeidsmiljø, i en internasjonal virksomhet. Vi har fokus på kompetanseutvikling, og drives alle mot et felles mål hvor...
-
Project Controller
4 weeks ago
Oslo, Norway Nexans Full timeWelcoming you to the team In this role, you will be part of the operation team in our business group G&T (Generation and Transmission) specializing in the execution of turn-key and supply-only contracts for Subsea and Land cable manufacturing and installation around the globe. Location: Oslo, Norway or Paris, France. Getting a flying start The...
-
Risk Expert/Senior Risk Expert
21 hours ago
Oslo, Norway Nordea Bank Full timeJob ID: 24358 Nordea is growing in Norway and we are looking for credit risk experts who wish to make a difference and develop Nordea’s credit risk framework and processes for our retail customers and credit automation. Do you have experience in handling household customers and are you interested in further developing Nordea’s risk management...
-
Manager- Land and License
1 month ago
Oslo, Norway Statkraft Full timeCompany Description As part of the Norwegian state owned Statkraft Group, Statkraft has been in India since 2004 and was the first foreign investor in Indian hydropower sector. The objective is to become a significant renewable energy independent power producer in India over the next few years. If you have a relevant experience in Land acquisition &...
-
Tender & Project Purchasing Manager
1 day ago
Oslo, Norway Nexans Full timeTender & Project Purchasing Manager Onboarding you to the Company At Nexans our global vision is to electrify the future. At our business group ‘Generation & Transmission’ this means providing reliable cabling systems and smart energy solutions, including power accessories, to make buildings and power networks more efficient, more people...
-
Head of Engineering Management
3 days ago
Oslo, Norway NOV Inc Full timeCLOSING DATE 9 JUNE 2024 NOV Norway is seeking an experienced Head of Engineering Management. In this role you will leading the team of Project Engineering Managers, Improving Engineering Management way of working and actively participate as Project Engineering Manager on a need basis. Manage all activities of engineering management within the Execution...
-
Customer Success Manager
3 weeks ago
Oslo, Norway Two Full timeAt Two, we’re fixing b-commerce with BNPL for B2B! We’re passionate about building solutions that enable B2B Merchants to sell more, faster, and more efficiently. Growing at a rapid pace, our goal is to become the world’s largest B2B payment solution by 2025.Two is built by a passionate and energetic team, all working together to revolutionise the way...