RemoteLeaf Logo
Log in Sign up

Senior Clinical Trial Manager - Job ID: SCTM

1 month 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

Similar Roles

Real Chemistry

Project Manager, Promotional Medical Education

Real Chemistry 1K-5K Professional Services

Real Chemistry is hiring a Project Manager for its Promotional Medical Education team to lead healthcare marketing projects from planning through delivery across cross-functional agency and client teams.

United States Full-time Mid Level Project Manager
$70k-$85k
8 hours, 23 minutes ago
Anduril Industries

Deployment Lead, PACOM

Anduril Industries 1K-5K Aerospace & Defense

Anduril Industries is hiring a Mission Operations Deployment Lead to deliver, sustain, and continuously improve CUAS capability for defense customers in field environments.

Japan Full-time Senior Program Manager Project Manager
$112k-$149k
Computer Vision CRM
8 hours, 38 minutes ago
Olsson

NEPA Specialist (Transportation/FRA)

Olsson 1K-5K Construction & Engineering

Olsson is seeking an Environmental and Permitting Specialist to lead environmental review, permitting, and compliance work for complex transportation projects while coordinating with clients, agencies, and project teams.

Anywhere Full-time Senior Project Manager
$79k-$120k
8 hours, 53 minutes ago
Avalere Health

Account Supervisor (Pharma Agency)

Avalere Health Professional Services

Avalere Health is hiring an Account Supervisor to manage digital pharmaceutical brand accounts, with a focus on website work and CIDP, while serving as a client-facing partner and coordinating cross-functional delivery.

United States Full-time Senior Marketing Manager Project Manager
$100k-$112k
Agile Digital Marketing
8 hours, 53 minutes ago

You're on a roll! Sign up now to keep applying.

Sign Up

Already have an account? Log in

Used by 14,729+ remote workers