Clinical Trial Manager
Ascendis Pharma, United States

• Plan, drive and coordinate operational aspects of clinical trial execution from initiation, planning, execution, maintenance and close-out
• Ensure clinical trials are executed according to external regulations and internal procedures
• If Global CTM, accountable for meeting corporate and departmental goals related to a clinical trial; delegate specific activities to Regional CTMs, as appropriate
• Participate in internal clinical trial team meeting
• Give input to clinical trial protocols in collaboration with the GCPL, Medical Expert or Clinical Scientist.
• Provide input to patient information/consent, eCRF forms and completion guidelines, site instructions for specimen collections, study drug order forms, etc.
• Author, give input to or review trial plans, such as Project Management Plan, Enrolment Plan, Monitoring Plan, Protocol Deviation Plan, etc.
• Participate in identification, qualification, initiation and close-out of clinical trial sites.
• Participate in identification, assessment and selection of relevant CROs and vendors; for example, central and special laboratories and imaging service providers.
• Manage and oversee contracted CROs and vendors; identify potential risks and resolve issues with CROs; establish vendor management plans and review quality metrics.
• Plan Monitor and Investigator Meetings and other training related activities for sites and vendors, as needed
• Review protocol deviations and data listings.
• Support IRB/IEC and regulatory submissions, as needed.
• Communicate directly with trial site staff and investigators to support the relationship between the sponsor and site; including co-monitoring visits.
• Review and approve vendor invoices.
• Perform periodic review of the electronic Trial Master File (eTMF)
• Support safety reporting.
• Maintain and report metrics for trial tracking and clinical site performance, including patient recruitment and retention.
• Contribute to Ascendis’ clinical Quality Management System by authoring or contributing to clinical SOPs.
• Work with CROs to prepare sites for clinical audits and to respond to audit findings conducted by Clinical QA and external regulatory agencies
• Contribute to clinical study reports, protocol amendments, data analysis review and study strategic development when needed
• Prepare for and participate in regulatory inspections
• Perform monitoring oversight visits (onsite or remote)
• Attend site visits (PSSVs, SIVs, motivational) as needed

Requirements

• BSc or MSc in natural or health sciences (biology, pharmacology, pharmaceutical sciences or equivalent)
• Minimum 3 years of experience within clinical operations or related function
• Experience with one or more phases in clinical trial conduct; setup, maintenance and closure
• Some understanding of one or more adjacent key functions, including medical, biometrics, regulatory and clinical trial supplies
• General understanding of the drug development process
• Ability to communicate with individuals in a respectful way
• Decision making abilities, but knows when to ask for advice
• Structured, organized and a proactive problem-solver, striking the right balance between detail and progress
• Good writing, communication and presentation skills
• Experience working in global/virtual teams

Benefits

• Medical insurance
• Vision insurance
• Dental insurance
• 401(k)
• Paid maternity leave
• Paid paternity leave
• Commuter benefits
• Disability insurance

Job Rewards and Benefits