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Senior Clinical Trial Manager - Job ID: SCTM

3 weeks, 2 days ago
United States
Full-time
Senior
Project Manager
Project and Program Management
Apply Now
Ascendis Pharma

Ascendis Pharma

Ascendis Pharma is a global biopharmaceutical firm that utilizes its innovative TransCon technology platform to develop new therapies aimed at enhancing treatment safety, efficacy, tolerability, and convenience for patients.

Pharmaceuticals
251-1K
Founded 2007
View All Jobs 2

Description

  • Foster and maintain positive relationships with clinical sites and investigators, including supporting informational calls and investigator meetings.
  • Review monitoring reports, track monitoring metrics, and ensure compliance with study protocols, regulations, and ICH/GCP.
  • Generate and analyze study metrics from systems such as CTMS and DM query trends to identify issues and communicate them to leadership and CRAs.
  • Manage protocol deviation reporting, follow-up actions, and related communication with monitoring teams and review groups.
  • Conduct monitoring team meetings, prepare agendas and minutes, and track training, report quality issues, site trends, and EDC metrics.
  • Support study team and site training, re-training, and investigator/site staff readiness activities.
  • Maintain Trial Master File and Investigator Site Files in Veeva Vault, including quarterly eTMF reviews and completeness checks.
  • Manage or support vendors and site-facing systems for central lab, IRB, imaging, patient concierge, site payments, EDC, and IRT access.
  • Support study start-up and conduct activities such as informed consent review, IRB/IEC and regulatory submissions, and GCP audit preparation.
  • Coordinate logistics for supplies, shipments, sample tracking, IMP tracking, study team meetings, CRA transitions, and data quality activities.

Requirements

  • Bachelor’s or master’s degree in natural or health sciences, such as biology, pharmacology, pharmaceutical sciences, or a related field.
  • 7+ years of combined experience managing or monitoring Phase 1, 2, or 3 clinical trials.
  • Strong working knowledge of ICH-GCP, relevant SOPs, work instructions, and regulatory guidance.
  • Direct work experience in a cross-functional environment.
  • Experience managing and overseeing vendors.
  • Experience performing clinical site monitoring visits, including remote visits.
  • High proficiency in English with strong communication and presentation skills.
  • Ability to prioritize, work independently, manage timelines, and communicate clearly with sites and stakeholders.
  • High proficiency with Veeva Systems (Clinical Vault eTMF, Veeva EDC), CTMS, Endpoint IRT, and Microsoft Office (Outlook, Word, Excel, PowerPoint).
  • Ability to travel up to 20% domestically for investigator meetings, remote employee meetings, and co-monitoring as needed.

Benefits

  • Estimated salary range of $160K-$170K DOE.
  • Eligible for a discretionary annual bonus or incentive compensation plan.
  • Eligible for discretionary stock-based long-term incentives.
  • Paid time off.
  • Comprehensive benefits package.
  • 401(k) plan with company match.
  • Medical, dental, and vision insurance.
  • Life, AD&D, short-term disability, and long-term disability coverage.
  • Employee assistance program, mental health resources, and paid leave for new parents.
  • Professional development support, employee discounts, HSA and FSA options, pet insurance, legal insurance, and additional supplemental insurance offerings.

Interested in this position?

Apply directly on the company website

Apply Now

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