Clinical Trial Manager

2 weeks ago

Palo Alto, California, United States Ascendis Pharma Full time

Here at Ascendis we pride ourselves in exceptional science, visionary leadership, skilled and passionate colleagues.

We are a dynamic, fast-growing biopharma company with offices in Denmark, Germany, and the United States. Today, we're advancing programs in Endocrinology Rare Disease, and Oncology.

Guided by our core values of patients, science, and passion, we use our TransCon drug development platform to fulfill our mission of developing new and potentially best-in-class therapies to address unmet medical needs.

Our culture fosters a place where skilled, adaptable, and highly resourceful professionals can truly make their mark. We are a dynamic workplace for employees to grow and develop their skills.

Responsibilities:

  • 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

Main tasks:

  • Work with the Clinical Science team to review and clean data
  • Manage the logistics for the Safety Review Committee (SRC)
  • Participate in internal clinical trial team meetings
  • Give input to clinical trial protocols in collaboration with the GCPL, Medical Expert or Clinical Scientist.
  • Participate in identification, assessment and selection of relevant CROs and vendors; for example, central and special laboratories and imaging service providers.
  • Participate in identification, qualification, initiation and close-out of clinical trial sites.
  • Author, give input to or review trial plans, such as Project Management Plan, Enrolment Plan, Monitoring Plan, Protocol Deviation Plan, etc.
  • Provide input to patient information/consent, eCRF forms and completion guidelines, site instructions for specimen collections, study drug order forms, etc.
  • 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
  • Salary $60-75/hour

Benefits

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

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