Tue, 05 Mar 2024 14:54:37 GMT

Senior Director, Clinical Data Management, Endocrinology
Ascendis Pharma, Denmark

Experience
1 Year
Salary
0 - 0
Job Type
Job Shift
Job Category
Traveling
No
Career Level
Telecommute
No
Qualification
As mentioned in job details
Total Vacancies
1 Job
Posted on
Feb 7, 2024
Last Date
Mar 7, 2024
Location(s)

Job Description

Are you passionate about driving excellence in clinical data management and thrive in a global, collaborative, and fast-paced environment? Do you have deep understanding of clinical data management processes and systems combined with leadership experience? If so, now is your chance to join Ascendis Pharma as our newSenior Director, Clinical Data Management, Endocrinology.

Ascendis Pharma is afast-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 Director, Clinical Data Management, Endocrinologyyou will join Clinical Operations, Endocrinology consisting of Clinical Data Management, Clinical Trial Management and Clinical Trial Supply. You will play a pivotal role in ensuring the highest standards of data quality, integrity, and regulatory compliance. The position requires a strong background in clinical data management, excellent team management skills, and the ability to drive operational excellence in a global setting. You will report to the SVP, Clinical Operations, Endocrinology.

Main areas of responsibility:

  • In collaboration with your US counterpart, provide strategic and tactical direction for clinical data management systems and operations, aligning with organizational goals and regulatory requirements.
  • Develop and implement innovative approaches to enhance data quality, streamline processes, and maximize operational efficiency.
  • Lead and mentor a high-performing team of clinical data managers, fostering a culture of collaboration, accountability, and continuous improvement.
  • Provide guidance on study-specific data management activities and ensure team members are equipped to meet ambitious project timelines.
  • Oversee the end-to-end data management process for clinical trials, from study start-up to database lock.
  • Collaborate with cross-functional teams to develop and implement data collection and validation procedures, ensuring data accuracy and completeness.
  • Ensure compliance with industry standards, Good Clinical Practice (GCP), and relevant regulatory requirements.
  • Evaluate and implement advanced technologies and tools to enhance data management capabilities.
  • Collaborate with IT teams to ensure seamless integration of data management systems and databases.

Your background includes an advanced degree (minimum B.Sc.) in a relevant scientific or technical field with at least 15 years of experience in clinical data management within the pharmaceutical, biotechnology, or CRO industry. You have a holistic understanding of the drug development value chain and are curious about needs and priorities of adjacent areas. Further, you have:

  • Proven leadership experience with a track record of successfully managing and developing high-performing teams.
  • Strong knowledge of regulatory guidelines and industry best practices related to clinical data management, including working knowledge of data standards (CDISC, CDASH, SDTM) and data collection platforms, including eCOA, in the clinical environment.
  • Experience working in a partly outsourced model through CROs will be preferable.
  • Flexibility to have overlap of work hours with colleagues based in United States.
  • Proficiency in English at a professional level, both written and spoken.

As a person, you have excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams. You thrive in a dynamic environment with short lines of communication and an open and informal working atmosphere. It is important that you can handle and interpret ambiguity to create clarity for your peers and reports.

Travel:Up to 15days 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 detailsabout the position or the company, please contact Claus Strange, SVP Clinical Operation,Endocrinology on or +45 24441330, or visit our website www.ascendispharma.com.

All applications must be submitted in English and are treated confidentially.

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 haveImpact conversationsabout 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.
  • To ensure a balanced approach to the office, all employees have the opportunity to work from home up to two days per week.

Job Specification

Job Rewards and Benefits

Ascendis Pharma

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