- Providing operational input to clinical trial protocols in collaboration with the Lead CTM and the trial team.
- Contributing to the development of patient information/consent forms, data collection forms, eCRF completion guidelines, trial specific manuals etc.
- Participating in selection of relevant CROs and vendors. Management and oversight of contracted CROs and vendors, including establishing vendor management plans.
- Participating in identification, qualification, initiation, and close-out of clinical trial sites.
- Operational set-up of the trials, including contribution to operational management plans, such as Trial Management Plan, Monitoring Plan, Protocol Deviation Plan etc.
- Maintain and report metrics for trial progress and clinical site performance, including start-up activities, and patient recruitment and retention.
- Communicating with trial site staff, including investigators, to facilitate relationship and engagement between the Ascendis and trial sites. Participating in co-monitoring visits.
- Reviewing protocol deviations and data listings, and support safety reporting.
- Oversight and QC of the TMF.
- Planning and participating in Monitor and Investigator Meetings.
- Support IRC/IEC and regulatory submissions, as needed.
- Contribute to Ascendis clinical Quality Management System by contributing to clinical SOPs.
- Project management mindset with a good understanding of the drug development process.
- Experience with all aspects of clinical trial conduct from planning and start-up, through maintenance and to closure.
- Thorough understanding of GCP and relevant regulatory guidelines and know how to apply it to your work.
- Structure, organized and a proactive problem-solver, striking the right balance between detail and progress.
- Team player who understands and appreciates how to build effective relationships with both internal and external stakeholders.
- Flexible and highly committed to delivering outstanding results.
-
Gentofte Hospital Hellerup, Danmark TEMPORARYEr du en stærk analytiker med erfaring i at planlægge og udføre kliniske forsøg? Vil du være ansvarlig for at starte nye internationale kliniske forsøg op i Danmark sammen med vores samarbejdspartnere? Kunne du tænke dig at arbejde med at gøre vores vision om kortere vej fra fors ...
-
Manager, Clinical Trial Planning
for 5 dage siden
Genmab Copenhagen, DanmarkAt Genmab, we're committed to building extra(not)ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
-
Manager, Clinical Trial Planning
for 6 dage siden
Genmab Copenhagen, Danmark FuldtidAt Genmab, we're committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, ca ...
-
Herlev og Gentofte Hospital Hellerup, Danmark AkademikereEr du en stærk analytiker med erfaring i at planlægge og udføre kliniske forsøg? Vil du være ansvarlig for at starte nye internationale kliniske forsøg op i Danmark sammen med vores samarbejdspartnere? Kunne du tænke dig at arbejde med at gøre vores vision om kortere vej fra fors ...
-
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
for 1 uge siden
Ascendis Pharma A/S Hellerup, Danmark FuldtidAre 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 Ascen ...
-
Associate Director Regulatory Affairs, Device
for 1 uge siden
Ascendis Pharma Hellerup, Danmark FuldtidAre you experienced within device regulatory affairs and are you passionate about finding new pathways for approval of combination products then this might be an interesting job for you · The role · Ascendis Pharmais a fast-growing, dynamic biopharmaceutical company with Headqua ...
-
Associate Director Regulatory Affairs, Device
for 1 uge siden
ASCENDIS PHARMA A/S Hellerup, Danmark FuldtidAre you experienced within device regulatory affairs and are you passionate about finding new pathways for approval of combination products then this might be an interesting job for you · The role · Ascendis Pharmais a fast-growing, dynamic biopharmaceutical company with Headqua ...
-
IT System Manager
for 1 uge siden
ASCENDIS PHARMA A/S Hellerup, Danmark FuldtidDo you get excited about making good applications even better? And do you have an interest in understanding application configuration as well as business processes? · Then you might be our new IT System Manager. · Ascendis Pharma is a visionary and ambitious company, which offer ...
-
Medical Lead Oncology
for 1 uge siden
Unique Human Capital A/S Charlottenlund, Danmark FuldtidExciting Medical Lead Oncology position in an innovative biopharmaceutical company · Nykode Therapeutics is seeking a strategy-driven Medical Lead Oncology to join the Oncology team. · As Medical Lead Oncology at Nykode Therapeutics, you will create and drive the clinical develop ...
-
Development Scientist, Virology and Virus Safety
for 4 dage siden
Novo Nordisk Gentofte, DanmarkAre you passionate about virology and virus safety? Do you have experience in downstream purification processes? We are looking for a talented Development Scientist to join our Virology and Cell Banks department in Novo Nordisk. · If you are ready for exciting challenges and wan ...
-
Senior Clinical Project Manager
for 1 uge siden
TFS HealthScience Søborg, Danmark FuldtidJoin our innovative team at TFS HealthScience as we continue our commitment to advancing clinical research and improving patient outcomes. We are currently seeking a talented Senior Clinical Project Manager to lead clinical studies and drive the development of life-changing treat ...
-
Clinical Operations Lead
for 4 dage siden
Novo Nordisk Søborg, DanmarkThe position · We are looking for a Clinical Operation Leads in all our 5 areas. In this position, you take on a senior role with extensive responsibilities, being accountable for all aspects of the operational start-up and initiation activities of a clinical trial. Your main re ...
-
SVP Communication Partner, Global Trial Portfolio
for 4 dage siden
Novo Nordisk A/S Søborg, DanmarkAre you passionate about leadership communication and translating strategy into concrete and meaningful actions? Are you an experienced (corporate) communication professional with experience in strategic communication, leadership communication, and change communication? · We are ...
-
EU Submission Lead for Clinical Trials
for 1 uge siden
Novo Nordisk A/S Søborg, DanmarkAre you ready to play a crucial role in driving and coordinating multiple tasks with challenging timelines? Do you have experience in regulatory affairs or clinical trials? We are looking for a motivated EU Submission Lead for Clinical Trials to join our newly established virtual ...
-
Statistical Specialist
for 2 dage siden
Novo Nordisk A/S Søborg, DanmarkAre you a highly experienced statistician looking for an opportunity to use your statistical knowledge and quality mindset to bring clinical projects to registration and market? Are you ready to work with our broad and expanding pipeline? Do you thrive in an inclusive, engaging, ...
-
EU Submission Lead for Clinical Trials
for 1 uge siden
Novo Nordisk Søborg, DanmarkThe position · As an EU Submission Lead for Clinical Trials, you will play a crucial role in driving, coordinating, and actively following up on multiple tasks with challenging timelines. Your responsibilities will include: Working closely with various submission teams across th ...
-
Biostatistics Outsourcing Specialist
for 3 dage siden
Novo Nordisk A/S Søborg, DanmarkDo you have experience in working with clinical trial programming and a firm knowledge of clinical drug development? And do you have a strategic mindset and strong communication skills as well as an interest in working with suppliers within Biostatistics? · You might be the one w ...
-
Director of Clinical Trial Simulations
for 1 uge siden
Novo Nordisk A/S Søborg, DanmarkAre you prepared to be a game-changer in drug development? Do you possess the leadership and the technical expertise to refine clinical drug development through the power of clinical trial simulations? If so, we invite you to join our dynamic Pharmacometrics team at Novo Nordisk. ...
-
EU Submission Lead for Clinical Trials
for 1 uge siden
Novo Nordisk Søborg, DanmarkAre you ready to play a crucial role in driving and coordinating multiple tasks with challenging timelines? Do you have experience in regulatory affairs or clinical trials? We are looking for a motivated EU Submission Lead for Clinical Trials to join our newly established virtual ...
Clinical Trial Manager - Hellerup, Danmark - Ascendis Pharma
Beskrivelse
Are you passionate about clinical trial management and do you want to take part in paving the way in a fast-growing and innovative biopharmaceutical company? Then this is a great opportunity for you.....
The role
As Clinical Trial Manager, you will be responsible for the effective conduct of global clinical trials within one of Ascendis' endocrine rare disease programs. You will be part of the cross-functional trial team driving Ascendis' clinical trials to completion according to agreed timelines and quality and will therefore contribute to directly to Ascendis' focus on making a meaningful difference in patients' lives. You will report to the Director, Clinical Operations and join a team of6 colleagues in a truly global organization with locations in Denmark, US, and Germany.
Ascendis Pharma is a fast-growing, dynamic biopharmaceutical company with Headquarters in Denmark that offers you room to grow and the freedom to take responsibility and make a difference for patients every day. As a member of our global team, you will work with highly skilled and passionate colleagues to advance our exciting product pipeline.
You will be responsible for:
Your professional qualifications
You hold a relevant bachelor's or master's degree in natural or health science (biology, pharmacology, pharmaceutical science or equivalent) and have minimum five years of experience in managing clinical trials. You have experience with day-to-day operational management and oversight of clinical trials. You are proficient in English at a professional level, both written and spoken.
Furthermore, you have:
As a person, you are:
Travel: 10-20days per year.
Office location: Hellerup, Denmark
For more details about the position or the company, please contact Betina Steenberg, Director Clinical Operations on or or visit our 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.