- Lead and provide oversight for the clinical data management activities from start-up to closure
- Serve as the inter-department subject matter expert for CDM within the assigned clinical studies
- Ensure the quality of clinical data meet standards for regulatory submissions
- Manage, collaborate, and act as the primary point of contact with CRO partner to ensure quality deliverables within expected timelines
- Serve as primary clinical data management contact within the clinical study team and ensure effective communication and collaboration
- Strengthening the collaboration and cultivating strong relationships to the key stakeholders and vendors within the project
- Provide technical and functional oversight of the day-to-day work within the assigned projects, as needed
- Contribute / lead non-clinical initiatives, and assist with implementing the corporate strategic plan within the department
- You may support the overall strategy and development of Clinical Data Management organization by participating in task force initiatives within the department. Your Profile
A minimum of 10 years of clinical data management experience from pharma, biotech or CRO and a relevant academic degree in life sciences (e.g. data science, computer science, pharmacy, biology, statistics).
Furthermore, you have:
- Hands-on data management experience from start-up to closure
- Demonstrated oversight experience and leadership quality, and superior organizational and interpersonal skills
- Knowledge of the current industry best practices, FDA, EMA and ICH regulations, ICH-GCP, GCDMP and other applicable local and international regulations
- Working knowledge of data standards (CDISC, CDASH, SDTM) in the clinical environment
- Working knowledge of different EDC platforms and data collection tools such as ePRO
- Prior experience supporting a BLA or NDA filing preferred
- Experience mentoring more junior clinical data managers
- Flexibility to have couple of hours of overlap of work hours with colleagues based in Palo Alto, California Also, you are proficient in English at a professional level, both written and spoken. As a person, you are a strong team player, proactive in nature and have a can-do attitude. As we are taking new steps towards developing best-in-class therapeutics for patients with rare diseases we are looking for people who possess an entrepreneurial mindset who can handle ambiguity, analyze, and create clarity and desires to be part of an organization where everything isn't set in stone. We rely on you to help us shape the cement and be part of building the biometrics team in the Copenhagen office. The person we are looking for thrives in a dynamic environment, short lines of communication and an open and informal working atmosphere.
Travel: Up to days per year.
Place of work: Ascendis Pharma headquarter resides in a modern and wonderful office facility in Tuborg Havn in Hellerup with a view of the harbor, the canals, and the sea.
For more details about the position or the company, please contact Peter Bayer, Senior Director of Clinical Data Management, Endocrinology, via or visit out website
All applications must be submitted in English and are treated confidentially.
Applications will be evaluated when received, so please apply as soon as possible.
-
Data Management Analyst
for 4 dage siden
Pandora Copenhagen, Danmark FuldtidDo you want to be a part of the world's leading jewellery company while putting your experience in technology into use? If yes, then we might have an exciting opportunity for you You will be part of an exciting digital & tech area and work in an international organisation of can- ...
-
Data Manager Analytics
for 1 dag siden
Publicis Sapient Copenhagen, Danmark FuldtidJob Description · We are seeking a Data Manager Analytics, with excellent strategic, analytical, technical, stakeholder management, communication and presentation skills, who is eager to share in the successes of a small, dedicated, growth-driven team. · As part of our evolving ...
-
Data Manager Analytics
for 4 dage siden
Publicis Sapient Copenhagen, Danmark FuldtidJob Description · We are seeking a Data Manager Analytics, with excellent strategic, analytical, technical, stakeholder management, communication and presentation skills, who is eager to share in the successes of a small, dedicated, growth-driven team. · As part of our evolving D ...
-
Data Governance Manager
for 1 uge siden
Pandora Copenhagen, Danmark FuldtidDo you want to be a part of the world's leading jewellery company while putting your experience in technology into use? If yes, then we might have an exciting opportunity for you You will be part of an exciting digital & tech area and work in an international organisation of can- ...
-
Data Centre Project Manager
for 2 dage siden
COWI Lyngby, DanmarkDo you want to be responsible for designing electrical systems in data centres? Are you an electrical engineer with experience in project management? And do you want to join a professionally strong environment? Then become one of COWI's data centre specialists. Turn challenges in ...
-
Energy Data Management Consultant
for 1 uge siden
Epam Copenhagen, DanmarkDescription · ABOUT THE ROLE · Embark on a dynamic journey with EPAM as a Data Management Consultant, bringing your expertise to the forefront of the oil and gas industry. Guide clients on data best practices, OSDU data platform, and Upstream processes. Engage with clients, con ...
-
Organisational Change Manager- Data Science
for 1 uge siden
Novo Nordisk A/S Søborg, DanmarkAre you passionate about organisational change management (OCM)? Are you an experienced organisational change and stakeholder manager? Do you have strong experience translating strategy and digital products into concrete, meaningful, and impactful initiatives, and do you thrive i ...
-
Organisational Change Manager- Data Science
for 1 uge siden
Novo Nordisk Søborg, DanmarkThe position · As organisational change manager you will be part of our organisational organisational change management team in Data Science Strategic & Digital Development. You will primarily work within our agile set up and together with the agile teams that are developing our ...
-
Senior Data Product Manager
for 3 dage siden
Kitab Sawti Copenhagen, DanmarkStorytel is one of the world's leading audiobook and ebook streaming services, and we offer unlimited listening to consumers in 25+ markets. Our vision is to make the world more empathetic, with great stories to be shared and enjoyed by anyone, anywhere, anytime. · At Storytel we ...
-
Organisational Change Manager- Data Science
for 1 uge siden
Novo Nordisk Søborg, DanmarkAre you passionate about organisational change management (OCM)? Are you an experienced organisational change and stakeholder manager? Do you have strong experience translating strategy and digital products into concrete, meaningful, and impactful initiatives, and do you thrive i ...
-
Project Manager in Data Science Strategic Projects
for 1 uge siden
Novo Nordisk A/S Søborg, DanmarkDo you want to join Data Science – a fast-moving and transforming organisation with the aim to be global leader in this field? · Do you have a passion for project management and a flair for driving change? Do you want to be part of shaping the direction of Data Science in Novo N ...
-
Project Manager in Data Science Strategic Projects
for 2 dage siden
Novo Nordisk Søborg, DanmarkDo you want to join Data Science – a fast-moving and transforming organisation with the aim to be global leader in this field? · Do you have a passion for project management and a flair for driving change? Do you want to be part of shaping the direction of Data Science in Novo N ...
-
Project Manager in Data Science Strategic Projects
for 1 uge siden
Novo Nordisk Søborg, DanmarkDo you want to join Data Science – a fast-moving and transforming organisation with the aim to be global leader in this field? · Do you have a passion for project management and a flair for driving change? Do you want to be part of shaping the direction of Data Science in Novo N ...
-
Project Manager in Data Science Strategic Projects
for 1 uge siden
Novo Nordisk Søborg, DanmarkThe position · You will be responsible for driving cross-functional projects in DS as well as across the broader R&D and Novo Nordisk organisation, reporting to the Head of Strategic Projects in Strategic & Digital Development. Projects are within areas such as defining the stra ...
-
Data Entry and Exploration Platform Project Manager
for 1 dag siden
Danish Refugee Council Copenhagen, Danmark· Job Description · Description · –> · The DEEP Project Manager main role and responsibility is to support the strategic development and rollout of DEEP, promote and ensure community engagement, and manage DEEP projects and grants.The DEEP Project Manager will be based in DRC's ...
-
Head of Personal Banking Data Privacy Risk Management
for 1 uge siden
Nordea Bank KøbenhavnS, DanmarkJob 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 pro ...
-
Senior Director, Team Lead, Clinical Data Management
for 1 uge siden
Genmab A/S Valby, Danmark FuldtidThe Role · The Director, Team Lead, Clinical Data Management, is operationally responsible for the oversight of Clinical Data Management activities related to the effective planning and timely delivery of complete, high quality and reliable clinical trial data. The Director, DM ...
-
SAP Master Data Management Associate
for 1 uge siden
FUJIFILM Diosynth Biotechnologies Hillerød, Danmark FuldtidCan you provide knowledge and support within SAP Master Data Management? · Do you thrive in an environment where you collaborate with colleagues across various functions and sites to help manage and optimize SAP Master Data processes in our SAP S4/Hana systems? · Then we hope you ...
-
Q-Manager
for 1 uge siden
MINDWEISS A/S Hellerup, Danmark FuldtidAnsøgningsfrist: · På vegne af vores kunde, Knorr-Bremse Rail Systems Denmark, søger vi en erfaren og proaktiv Q-Manager. Stillingen er en oplagt mulighed for at forme virksomhedens kvalitetsopgaver ved at anvende dine kompetencer inden for kvalitetsstyring og ledelsessystemer. ...
-
EDC/Clinical Programmer
for 1 uge siden
Ascendis Pharma A/S Hellerup, Danmark FuldtidAre you passionate about Clinical Data? Do you have solid experience building an eCRF in an EDC CDMS and/or clinical programing for complex studies? Are you familiar with clinical data management activities from start-up, conduct to closure?If so, now is your chance to join Ascen ...
Senior Specialist Clinical Data Manager - Hellerup, Danmark - Ascendis Pharma A/S
Beskrivelse
Are you passionate about Clinical Data Management? Do you have solid experience leading clinical data management activities for complex studies? Are you familiar with all clinical data management activities from start-up, conduct to closure? If so, now is your chance to join Ascendis Pharma as our new Senior Specialist, Clinical Data Management. Ascendis Pharma is a fast-growing biopharmaceutical company with locations in Denmark, Germany, and the United States. We are applying our TransCon technology to build a leading, fully integrated biopharmaceutical company with an independent pipeline of long-acting prodrug therapies that address unmet patient needs. As our new Senior Specialist, Clinical Data Manager, you have a deep understanding of clinical data management, and through your work you will be recognized as an expert. Your way of collaborating with internal and external stakeholders, will help you lead the data management study team to succeed. In this position you will be given broad responsibility tailored to our studies. You will oversee data management activities associated with the development, conduct, and management of assigned studies in endocrinology, and future therapeutic areas. You will provide oversight for across phase 1 to 4 trials serving as the lead data manager. You will work independently and collaboratively in a dynamic team environment. You will work closely with our Data Management CRO, EDC Study Start-up Lead, External Data Specialists, Biometrics, and the Clinical Study Teams ensuring quality study deliverables are met. As the primary point of contact for internal stakeholders and Vendors, your will actively guide, advise, and steer, when it comes to clinical data management activities. You will be joining the newly established Clinical Data Management team, Endocrinology in the Copenhagen office In this role you have a unique opportunity to be part of shaping the way we work within the Clinical Data Management organization. You bring with you a wealth of professional experience, you are passionate and have an eye for frameworks, processes, and best practices. We encourage you to think out of the box supporting the organization in doing an even better job, when preparing for future requirements. For the right candidate you will be given the mandate to participate or manage non-study initiatives and / or projects. You will be supported by line management, who has in depth clinical data management experience, who can challenge, and spar as needed, and who will pave the way for you to succeed. Throughout the year you and your manager will meet to perform deep dive communication, where well-being, growth and collaboration are on the agenda. Main areas of responsibility: