Clinical Trial Manager

The Clinical Trial Manager (CTM) is responsible for the delivery of all clinical aspects of the study. The CTM develops monitoring plans and tools, train applicable operations team members, drives enrollment and study start-up activities, may perform monitoring (or co-monitoring), liaises with sponsors, internal and external stakeholders, identifies and mitigates risks that may impact clinical delivery.

As a team member with NBCD you will have multiple opportunities to quickly advance your career in clinical research through our career and mentoring program. Being a global company, NBCD will also provide a network of international colleagues you will be able to interact and collaborate with.

The job:

  • Ensuring quality of the trial master file through content (QC) review of submitted documents and liaise with project teams to resolve any issues identified with submitted documents
  • Provide monitoring oversight including development of the clinical monitoring plan, performing co-monitoring visits, ensure that all monitoring activities are conducted according to timeline and with high quality
  • Serve as the clinical point person managing protocol execution, including the oversight of assigned vendors and consultants that are involved with the clinical trial
  • Participates in program meetings and ad hoc clinical operations’ initiatives 
  • Responsible for the preparation and review of clinical documentation such as the informed consent, clinical protocols, Investigator’s Brochure, and other study documentation
  • Participates in the request and review of scope of works, budgets, vendor performance, and issue resolution
  • Establish study milestone and ensure accurate tracking and reporting of study metrics and timelines
  • Responsible for executing one or more elements of clinical trials in compliance with ICH GCP, SOPs, and local applicable regulations
  • Provide study-specific mentor and training for clinical operation team members
  • May (depending on experience) manage direct reports, as required

Minimum Education and Qualifications:

  • Bachelor’s degree in life sciences, health, or other relevant field
  • Minimum 3 years of industry experience required with at least 1 year as a clinical trial manager, or equivalent experience
  • Excels in a fast-paced, high-growth company environment with a high degree of independence and is able to adjust workload based on changing priorities
  • Strong skills in collaboration, communication, organization and attention to details
  • Ability to handle multiple projects and utilize judgement to prioritize skills
  • Demonstrated leadership, problem-solving, conflict resolution, and team building skills
  • Ability to handle multiple projects and utilize judgement to prioritize tasks

Work location: Remote/home based

Application:

To apply please send your CV and a letter of motivation to aol@nbcd.com - we are looking forward to hearing from you!

For further information about the role contact Andreas Olofsson, Senior Director and US Head of CRO, at aol@nbcd.com. We are conducting interviews on a regular basis and will close the position when we find the right candidate.

We might use assessments as a part of the recruitment process.

We encourage all qualified candidates to apply for the position – regardless of ethnic background, gender, sexual orientation, disability, religion or age.

We value your data and take care to protect it. Please see more information regarding privacy for job applicants here.

About NBCD:

NBCD is the leading clinical CRO specialized in Osteoarthritis in Europe. The Danish based company is now looking to expand its operation in US. Joining this expansive team at an early stage will give you opportunities to grow your career rapidly together with the US organization. The company has +30 years of experience working with clinical trials, biomarker development and precision medicine. Working closely together with the partners in the Sanos Group, NBCD serves as a one-stop shop for clinical trials in osteoarthritis and adjacent therapeutic areas.   

For our permanent employees, NBCD offers a highly competitive package in terms of base and incentive compensation. In addition, we offer a comprehensive benefits program designed to support the health, wellness and financial security or our employees and their families. Benefits include medical, vision and dental coverage, 401(k) and more. The options for permanent employment or contracting will be discussed and agreed upon together with the candidate.