- Develop and Update Clinical Databases (EDC).
- Ensures adherence to clinical database standards, SOPs and Process Guidelines.
- Leads and/or participates in the review of eCRFs and validation checks, database development, programming of validation checks in Clinical Data Management System (CDMS).
- Interface with members of study teams, including external CROs/Vendors where applicable, to integrate study team requirements into all deliverables.
- Participates in extra activities including, but not limited to, evaluation and testing of new systems and helps coordinate CDM Systems technical initiatives. Contributes strategies, innovative and creative solutions to enhance processes and increase productivity of the group.
- Contribute to the ongoing development, review, and revisions of Standard Operating Procedures (SOPs), Work Instructions, Training and standard DM templates.
- Contribute to the development of CDM and EDC standards.
- Generate metric reports and listings to facilitate the management and review of external data, as required. Your Profile
A minimum of 6 years of clinical programming and/or EDC database development and 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:
- Demonstrated technical proficiency in a Clinical Data Management Systems (i.e. Veeva CDMS, Medidata Rave, Oracle Inform etc.).
- At least 4 years of EDC database development experience.
- At least 2 years of Programming experience preferably in SAS and SQL.
- Proficiency in cultivating and sustaining positive collaborative relationships across diverse functional areas.
- Keen emphasis on prompt action and prioritizing stakeholder needs.
- Project management capabilities encompassing effective group presentation, leadership, verbal and written communication, interpersonal adeptness, and organizational proficiency.
- Desire to learn new processes and technologies.
- Proficiency in multitasking, independent work, and effective communication.
- Well-versed in the drug discovery process, FDA regulations, GxP guidelines, ICH guidelines, clinical database cleaning procedures, and 21 CFR Part 11. 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 Clinical Data Management 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.
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EDC/Clinical Programmer - Hellerup, Danmark - Ascendis Pharma A/S
Beskrivelse
Are 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 Ascendis Pharma as our new EDC Clinical Programmer. 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 EDC/Clinical Programmer, you have a deep understanding of clinical data, and through your work you will be recognized as an expert. Your way of collaborating with internal and external stakeholders, will help the data management study team to succeed. In this position you will be given broad responsibility tailored to our studies. You will be involved in data management activities associated with the development, conduct, and management of assigned studies in endocrinology, and future therapeutic areas. You will provide expert knowledge and support across phase 1 to 4 trials serving as the EDC & Clinical Programmer to ensure the success of the trial. You will work independently and collaboratively in a dynamic team environment. You will work closely with our Data Management team, to ensuring quality study deliverables are met. As a key point of contact for internal stakeholders and Vendors, your will be actively involved together with the Clinical Data Manager on how best data can be captured as well ensuring with oversight of the clinical data both within DM and our stakeholders. You will be joining the newly established Clinical Data Management team in the Copenhagen office. In this role you have a unique opportunity to be part of shaping the way we work within the Global 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:
