Senior Specialist, Clinical Data Management
Ascendis Pharma
Are you passionate about Clinical Data Management? Do you have experience leading data management activities for complex studies? Are you familiar with all data management activities from start-up, conduct to closure?
If so, now is your chance to join Ascendis Pharma as our new Senior Data Manager/Associate Director, 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 Data Manager / Associate Director, Clinical Data Management you will be joining the Biometrics team in the Copenhagen office and work closely with Global Biometrics in the Palo Alto, US office.
You will lead and provide oversight for the clinical data management activities across phase 1 to 4, including serving as the lead data manager on studies in the assigned projects / program. You will work closely with the EDC Study Start-up Lead, the External Data Lead, and the study teams. You will be primary point of contact with CROs and ensure that study deliverables and timelines are met for outsourced studies.
Main areas of responsibility (depending on your skills and experience):
- Serve as the subject matter expert for CDM within the clinical study team / clinical project / program to enable planning, coordination, and timely delivery of complete, high quality and reliable clinical trial data
- Serve as primary clinical data management contact within the clinical study team and ensure effective communication and collaboration
- Manage, collaborate, and act as the primary point of contact with CROs to ensure that study deliverables and timelines are met for outsourced studies
- Ensure compliance from a CDM perspective regarding risk assessment, protocols, SOPs and overall clinical objectives within the assigned clinical program and trials
- Provide technical and functional oversight of the day-to-day work within the assigned projects, as needed
- Participate / lead non-clinical initiatives, and assist with implementing the corporate strategic plan within the department
- May manage direct reports as well as mentor junior data manager(s) and contractors, as required
Your key stakeholders will be:
- The Clinical Study team
- CROs
- External Vendors
- The biometrics organization
Your Profile
You hold a relevant academic degree – preferably a Bachelor’s degree in life sciences (e.g. biology, data science, computer science, statistics), and at least 5 - 8 years of relevant data management experience or equivalent combination of academic degree and relevant job experience
Furthermore, you have:
- Hands-on data management experience from start-up to closure
- Demonstrated project management experience / leadership qualify 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
- 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 og 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 5 - 15 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 visit our website www.ascendispharma.com. All applications must be submitted in English and are treated confidentially.
Applications will be evaluated when received, so please apply as soon as possible.
Benefits
- You can expect an attractive remuneration package, short- and long-term incentives, pension scheme and health insurance.
- Laptop, iPhone, paid internet, and home office equipment
- A thorough and structured onboarding program
- To succeed in your job and expand in your role, you and your manager will continuously have Impact conversations about how to propel your development. If a need is identified, we find a way to help you grow.
- Soft drinks, fresh fruit and a wide variety of snacks every day, no strings attached.
- To ensure a balanced approach to the office, all employees have the opportunity to work from home up to two days per week.