Clinical Project Manager/ Senior Manager

2 weeks ago

Helsingborg, Skåne, Sweden Pharmiweb Full time

Global Clinical Project Manager

Join our dynamic team, at an innovative biotech, as a proactive and highly motivated Global Clinical Project Manager (CPM) to drive the operational success of our global clinical-stage projects focused on antibody drug conjugates (ADCs). As the CPM, you will oversee clinical trial activities (Phase I-III) and ensure the timely and budget-conscious completion of studies with the highest quality. Reporting to the CMO, you will manage the planning, implementation, and tracking of the clinical monitoring process, as well as administer the clinical trials while maintaining a comprehensive overview of the studies within the Trial Team.

Responsibilities:

  • Take overall responsibility for Phase I-III clinical Projects, with potential expansion to subsequent trials as the program and portfolio grow.
  • Lead the cross-functional Trial Team (TTT) and manage day-to-day operations of the clinical study, ensuring alignment with established goals, objectives, and budget, in compliance with SOPs/GCP/ICH/regulatory requirements.
  • Manage interactions with multiple Clinical Research Organization (CRO) and clinical vendors/partners, coordinating clinical study timelines with Program Management to meet critical milestones.
  • Proactively address issues that may jeopardize deliverables and resolve challenges during study conduct.
  • Develop study plans and system set-up, perform country and site selection, and coordinate site management activities in collaboration with the team and CRO.
  • Guide, author, audit, or edit study documents, including data reports, training materials, operational manuals, protocol development, Case Report Form (CRF), Informed Consent Form (ICF) design, and Clinical Study Report (CSR) writing.
  • Facilitate the achievement of excellent data quality and oversee the trial budget.

Requirements:

  • Neurology experience ideally ALS
  • Experience designing, running and developing phase IIb clinical trials
  • Thorough understanding of the drug development process with a strong knowledge of ICH and GCP guidelines.
  • Extensive knowledge of clinical trial regulations, including US FDA and EMA
  • Strong experience in the management of multiple CROs and other vendors.
  • Influential and assertive communication skills (written and verbal).
  • Proven project management abilities and study leadership.
  • Ability to work independently and prioritise duties.
  • Proactive team player, striving to find the best solutions in a collegial team environment.
  • Fluent in written and spoken English.

  • Technical Project Manager to

    2 weeks ago

    Helsingborg, Skåne, Sweden Doro Full time

    At Doro, our purpose goes beyond creating mobile devices; we are dedicated to enriching the lives of seniors, providing them with the means to lead active and independent lives. Our commitment is to challenge ageism and foster inclusion, making technology accessible and user-friendly for the elderly. As we continue to position ourselves as Europe's leading...

  • Technical Project Manager to Doro, Malmö

    2 weeks ago

    Helsingborg, Skåne, Sweden Meet a Groups kund Full time

    Jobbify är en jobbplattform för vassa kandidater.För kunds räkning har vi publicerat denna annons, vill du komma i kontakt med den slutgiltiga arbetsgivaren kan du klicka dig vidare till annonsen:At Doro, our purpose goes beyond creating mobile devices; we are dedicated to enriching the lives of seniors, providing them with the means to lead active and...

  • Project Manager

    2 weeks ago

    Helsingborg, Skåne, Sweden Smartare Rekrytering Full time

    Project ManagerDo you want to be challenged in a fast-paced business where you have great opportunities for development and to influence your daily work? We are now looking for Project Managers to our shipyard in Landskrona, Sweden.About the positionThe main responsibilities of the project manager are to plan, organize and follow up the activities of the...

  • We are looking for a ServiceNow Project Manager

    2 weeks ago

    Helsingborg, Skåne, Sweden Northab Full time

    TasksPlanning, requirement gathering, and establishing scrum team(s)Interfacing with clients and managing deliverables, changes in scope, time, and scheduleAdvising senior client leadership and coming up with technical solutionsOverseeing project delivery, road map, and themes of workProviding accurate estimates and delivery timelinesServiceNow Project...

  • Project Manager

    2 weeks ago

    Helsingborg, Skåne, Sweden Alfa Laval Full time

    Alfa Laval in Lund is looking for a Local Project Manager for Project OrderAt Alfa Laval, we always go that extra mile to overcome the toughest challenges. Our driving force is to accelerate success for our customers, people, and planet. You can only achieve that by having dedicated people with a curious mind. Curiosity is the spark behind great ideas. And...

  • Digital ASIC Technical Project Manager

    2 weeks ago

    Helsingborg, Skåne, Sweden Axis Communications Full time

    Do you want to work with advanced ASIC development in the forefront of technology? Are you ready to join a team responsible for the very heart of the Axis products - the ARTPEC SoC chip - where your contribution really matters and where team collaboration is the way to success? We are now looking for a Digital ASIC Technical Project Manager to further...

  • EMEA R&D Technical Delivery Senior Manager

    2 weeks ago

    Helsingborg, Skåne, Sweden Kenvue Full time

    EMEA R&D Technical Delivery Senior Manager This role, reporting to the EMEA R&D Vice President and located in Helsingborg, Sweden, is a key position within our organization. Who We Are: At our company, we understand the significant influence of everyday care. With a rich heritage and a foundation in science, we are home to renowned brands such as NICORETTE,...

  • Engagement Manager

    2 weeks ago

    Helsingborg, Skåne, Sweden Quest Global Services Full time

    Quest Global is looking for an Engagament Manager to join our team in Helsingborg. We are seeking a leader to secure continued success in engaging with customers within the retail sector - with a focus on transforming on premises e-commerce to Google and Azure cloud.The project has a specific focus on:Current IT landscape assessmentDestination IT landscape...

  • Engagement Manager

    2 weeks ago

    Helsingborg, Skåne, Sweden Quest Global Services Pte Ltd Filial Sweden Full time

    Quest Global is looking for an Engagament Manager to join our team in Helsingborg. We are seeking a leader to secure continued success in engaging with customers within the retail sector - with a focus on transforming on premises e-commerce to Google and Azure cloud.The project has a specific focus on:Current IT landscape assessment Destination IT landscape...

  • EMEA Nutritional Development Senior Manager

    2 weeks ago

    Helsingborg, Skåne, Sweden Kenvue Full time

    EMEA Nutritional Development Senior ManagerThis role reports to the EMEA R&D Self Care Sr. Director and is located in Helsingborg, Sweden.About UsAt our company, we understand the remarkable power of daily care. With a rich heritage and a foundation in science, we are the home of renowned brands — including well-known OTC brands like NICORETTE, IPREN,...

  • EMEA Nutritional Development Senior Manager

    2 weeks ago

    Helsingborg, Skåne, Sweden Kenvue Full time

    Come work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation. Job Description - EMEA Nutritional Development Senior Manager W) EMEA Nutritional Development Senior Manager W Description This position reports into EMEA R&D Self Care Sr. Director and is based at Helsingborg, Sweden. This position...

  • EMEA R&D Technical Delivery Senior Manager

    2 weeks ago

    Helsingborg, Skåne, Sweden Kenvue Full time

    Investors Healthcare Professionals Media Careers Put your passion to workCome work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation. Explore Students & Recent Graduates Opportunities Go to the main content section. Welcome. You are not signed in. | My Account Options Sign In Beginning of the main...

  • Territory Manager, Endoscopy Solutions

    2 weeks ago

    Helsingborg, Skåne, Sweden Ambu Full time

    Are you ready to take on a challenging yet rewarding role at Ambu, a global player in the medical device industry? Ambu is on a mission to make a real impact by saving lives and enhancing patient care through cutting-edge medical devices and revolutionary single-use scopes. If you're enthusiastic about being part of a high-paced, rapidly expanding...

  • Territory Manager, Endoscopy Solutions

    2 weeks ago

    Helsingborg, Skåne, Sweden Ambu AS Full time

    Press Tab to Move to Skip to Content Link Territory Manager, Endoscopy Solutions (ESL) Country: Sweden Location: Helsingborg, SE City: Helsingborg Business Area: Sales Employment type: Full-time Are you looking to make a difference in your career and become part of an innovative, global medical device company? Ambu is comprised of team members who...

  • Category Project Manager to Cloetta in Malmö

    2 weeks ago

    Helsingborg, Skåne, Sweden Academic Work Full time

    Category Project Manager - Cloetta Global Innovation TeamAre you active, structured and love to get things going? Then this position in Cloetta's global innovation team is for you We are now looking for a Category Project Manager based in Malmö. Welcome to submit your application, as we are working with ongoing selection.ABOUT THE POSITIONCloetta has a...

  • Territory Manager, Peripheral Intervention

    2 weeks ago

    Helsingborg, Skåne, Sweden Moveup Consulting AB Full time

    Territory Manager, Peripheral Intervention (PI) – South/West SwedenAbout the roleWe have a phenomenal field-based opportunity for a Sales Specialist to join our Peripheral Interventions, BD Interventional Division (BDI), the successful candidate will run the South-/West Sweden territory.Reporting to the Nordic PI Sales Manager, you will be responsible for...

  • Purchasing Project Leader

    2 weeks ago

    Helsingborg, Skåne, Sweden Koenigsegg Automotive AB Full time

    The RoleThis position plays an integral role in driving improvements in Koenigsegg key metrics in the sourcing of all categories related to Direct Material. You will be the key player in the projects to coordinate and plan the purchasing and Supply Chain efforts. You will need to master the planning of resources needed in the project.As an employee at...

  • Senior Test Manager till

    2 weeks ago

    Helsingborg, Skåne, Sweden OneMed Full time

    Gör skillnad inom vården – som Senior Test Manager på OneMedNu finns möjligheten att bli en del av OneMed IT som Senior Test Manager. OneMed täcker hälso- och sjukvårdens behov när det kommer till medicinskt material, utrustning och beredskap - snabbt, smidigt och med kvalitet. Vi drivs av en trygg och säker vård samt av att förbättra...

  • Erfaren Project Manager till Nordomatic Malmö

    2 weeks ago

    Helsingborg, Skåne, Sweden Processbemanning AB Full time

    Erfaren Project Manager till Nordomatic MalmöNordomatic är ett specialiserat tillväxt- och kunskapsföretag som hjälper fastighetsägare att med modern teknik sänka energiförbrukning och driftskostnader. Bolagets vision är att bli Global Impact Leader of Smart Buildings och vägen dit skall gå via organisk tillväxt såväl som genom förvärv. Idag...

  • Manager Quality Management

    2 weeks ago

    Helsingborg, Skåne, Sweden Occlutech Full time

    Occlutech is a leading specialist provider of minimally invasive cardiac devices, with a mission to improve the quality of life for people with heart conditions. The vision is to become a global leading specialist provider in cardiac devices, addressing congenital heart defects, stroke prevention, and heart failure. Occlutech has a broad and proven...