Clinical Trials Manager

4 days ago


Copenhagen, Copenhagen, Denmark Novartis Full time

Job Description

We are seeking an experienced Medical Lead to join our team at Novartis. The successful candidate will have a strong background in Medical Affairs and will be responsible for ensuring medical enquiries are responded to in a high-quality, timely manner and in accordance with applicable standards.

Key Responsibilities

  • To ensure medical enquiries are responded to in a high-quality, timely manner and in accordance with applicable standards; establish standard response documents as appropriate, for frequently asked questions.
  • To provide medical/scientific input into the development and execution of clinical trial or clinical research related activities, including initiation and oversight of clinical studies/clinical research within the respective therapeutic area.
  • To support country strategy for Non-Interventional Studies/Investigator-Initiated Trial activities.
  • To coordinate review and approval of medical materials and locally developed promotional materials; ensure medical materials provided from global or region for stakeholder engagement and events are tailored to local needs, and reviewed/approved per local/P3 guidelines.
  • To ensure medical insights are provided to cross-functional groups, including, but not restricted to: Pharmacovigilance, Regulatory affairs, Market Access, QA, Commercial teams, Brand team and others.
  • To be responsible for risk identification and assessment, mitigation planning as well as implementation and monitoring of appropriate internal controls within the area of responsibilities.
  • To report technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt - Distribution of marketing samples (where applicable).

Requirements

  • Minimum 3 years of experience in Medical Affairs from the Pharma industry.
  • Life Sciences Degree.
  • Proficient Danish and English, both written and spoken.
  • Project Management.
  • Stakeholder Engagement.

Benefits

At Novartis, we offer a competitive salary and benefits package, including opportunities for professional growth and development.



  • Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    Job DescriptionWe are seeking a highly skilled Senior Clinical Operations Manager to join our team at Novo Nordisk. As a key member of our clinical operations department, you will be responsible for leading the execution of clinical projects in assigned therapeutic areas across Region Europe & Canada (EUCAN). Your primary focus will be on strategic planning,...


  • Copenhagen, Copenhagen, Denmark Black Swans Exist Full time

    We are looking for a seasoned Clinical Trial Program Manager to oversee the planning, execution, and delivery of our clinical trials. As a key member of our team, you will work closely with cross-functional teams to develop and implement trial strategies, manage trial timelines and budgets, and ensure compliance with regulatory requirements.About the JobThis...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    Job DescriptionWe are seeking a highly skilled Clinical Trials Disclosure Manager to join our team in Copenhagen or Utrecht.Your primary responsibility will be to ensure the disclosure of clinical trial protocols, results, and document redaction across our entire portfolio. You will work closely with trial teams to develop and maintain timelines for protocol...


  • Copenhagen, Copenhagen, Denmark MSD Danmark ApS Full time

    MSD Danmark ApS is a leading pharmaceutical company in Denmark, seeking a highly motivated Site Management Lead - Clinical Trials. This role is ideal for individuals who are passionate about conducting clinical trials and ensuring high site performance.In this position, you will be responsible for managing assigned trials and sites, working closely with the...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About the OpportunityWe're expanding our Clinical Trial Disclosure & Transparency team with a Sr. Associate/Manager position. This role offers a unique chance to work collaboratively with a talented team of professionals who share your passion for making a difference in patients' lives. As a key member of our team, you'll be instrumental in executing global...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our Clinical Trials team at Genmab A/S. As a key member of the team, you will be responsible for executing global and national clinical trial disclosure requirements across our entire portfolio.You will work closely with trial teams to ensure high-quality disclosure of clinical...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Job SummaryGenmab is seeking a highly skilled Sr. Associate/Manager to join our Clinical Trial Disclosure & Transparency team. In this role, you will be responsible for ensuring the successful execution of global and national clinical trial disclosure requirements, supporting trial teams, and overseeing the relationship with our disclosure vendor(s). Your...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    About UsGenmab is a pioneering biotechnology company dedicated to developing innovative antibody products that transform the lives of patients suffering from cancer and serious diseases. Our mission is to build extraordinary futures together by leveraging cutting-edge science and technology to create therapies that make a meaningful difference in people's...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    As a Global Disclosure Manager at Genmab A/S, you will play a crucial role in ensuring high-quality disclosure of clinical trial information and implementing new transparency requirements. You will be responsible for supporting trial teams, developing and maintaining timelines for protocol registration and results disclosure, and overseeing the relationship...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    Job DescriptionAs a Regulatory Affairs Specialist in our Clinical Trials team, you will be responsible for executing global and national clinical trial disclosure requirements across our entire portfolio.Key responsibilities include managing the public disclosure of clinical trial protocols, results, and document redaction, developing and maintaining...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    At Genmab A/S, we are seeking a highly skilled Clinical Trial Disclosure Specialist to join our team. As a key member of our Clinical Trial Disclosure & Transparency team, you will be responsible for executing global and national clinical trial disclosure requirements across our entire portfolio.Key ResponsibilitiesManage, track, and oversee public...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    Sr. Associate/Manager, Clinical Trial Disclosure & TransparencySr. Associate/Manager, Clinical Trial Disclosure & TransparencyLocation: This role can be based in Copenhagen, Denmark (DK), or Utrecht, Netherlands (NL), and offers a hybrid work arrangement.Role OverviewAs a Sr. Associate/Manager in the Clinical Trial Disclosure & Transparency team, you will be...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    Job OverviewAs a Regulatory Affairs Specialist in our Clinical Trials team, you will play a crucial role in ensuring the successful execution of global and national clinical trial disclosure requirements across our portfolio.Your key responsibilities will include managing the public disclosure of clinical trial protocols, results, and document redaction,...


  • Copenhagen, Copenhagen, Denmark Pharma IT Full time

    **Job Description**At Pharma IT, we are committed to delivering high-quality services to our clients in the pharma, biotech, and medical device industries. We are seeking a seasoned Clinical Project Management Consultant to join our Clinical Science & Trial Operations Team.In this role, you will lead the development and execution of clinical projects, from...


  • Copenhagen, Copenhagen, Denmark Genmab AS Full time

    Key ResponsibilitiesThe ideal candidate will have previous experience with clinical trial disclosure and a strong understanding of the pharmaceutical industry.They will be responsible for managing the public disclosure of clinical trial protocols, results, and document redaction, developing and maintaining timelines for protocol registration and results...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Job DescriptionWe are seeking an experienced Clinical Drug Supply Manager to join our Global Clinical Drug Supply Operations team in Copenhagen, DK or Princeton, NJ.The ideal candidate will have extensive knowledge of cGMP and a focus on the level of quality in work performed. They will manage outsourcing of packaging, labeling, and distribution of clinical...


  • Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    Do you dream of being part of regional clinical trial teams as we set out on a journey into new and exciting ways of working? Can you help us bring new treatments to patients, faster and smarter, by leading and optimizing trial work within your area of expertise? If yes, then you are the Senior Clinical Operations Manager we are looking for.The PositionAs a...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    Job SummaryWe're looking for a skilled Clinical Drug Supply Manager to join our team in Copenhagen, Denmark or Princeton, New Jersey.This role involves managing clinical trial supplies, collaborating with CMOs, and ensuring compliance with quality standards.About the TeamYou'll be part of a highly competent team focused on packaging and labeling of supplies...


  • Copenhagen, Copenhagen, Denmark Novo Nordisk AS Full time

    Clinical Operations DepartmentThe Clinical Operations department is responsible for setting up and executing phase 1-4 clinical trials within the area. Our environment is characterized by a vast global network and collaboration, knowledge sharing, talented colleagues, and challenging assignments in a dynamic project-centric organization.About the PositionAs...


  • Copenhagen, Copenhagen, Denmark Genmab Full time

    At Genmab, we're committed to building extraordinary futures together, by developing antibody products and pioneering 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...