Global Trial Director

TRIO is a unique, full-service clinical research organization (CRO) that leverages the strengths of our worldwide network of Investigators, academic leaders, patient advocates and our clinical research team to accelerate drug development.

TRIO is looking for a Global Trial Director to join our Project Management team in North America. Reporting to the VP of Project Management, this position will be a remote position based in Canada or USA.

Responsibilities:  

• Leads and is responsible for the overall coordination and management of one or more clinical trials from trial start-up to completion.
• Is accountable for the overall delivery (quality, timeliness and cost) of the clinical trial(s) under his/her supervision. 
• Leads and provides operational expertise/support to the trial team, composed of cross functional members assigned by each involved TRIO department ensuring all trial milestones and deliverables are achieved.
• Develops, reviews, and approves for the trial(s) they are overseeing: the trial timelines, including the deliverables; the trial management plans and operational documents; the training material for sites and trial team.
• Ensures adequate resources are allocated to the trial(s) with the input of the involved departments.
• Regularly reviews all trial metrics and follows-up with relevant cross functional team members as needed.
• Identifies and assesses the risks, develops risk mitigation strategies and implements remediation/action plans when required.
• Serves as the primary contact with the Sponsor on all trial aspects, provides regular updates on the trial progress.
• Delivers presentations (e.g. during Investigator Meetings).
• Mentors/manages PM team members involved in the trial(s) they are in charge of, enabling them to perform the tasks under their responsibility and to grow over time.
• Can be involved in selection process of and in interview with project management team candidates.
• Participates in the selection of new (global and regional) Third Party Organizations (TPOs) and in periodic reevaluations of TPOs and oversees the activities performed by the TPOs at the trial level.
• Works with all TRIO departments to ensure adequate data quality prior to database lock/freeze.
• Ensures the trial budget is managed accurately by:
• - Determining, with input from the trial team members, the need for Change Orders and ensuring the corresponding Change Orders are developed and submitted in a timely manner,
  - Reviewing monthly trial revenue and quarterly forecasting for appropriateness,
  - Participating in the monthly financial meetings to review the financial health of the assigned trials
• Participates in sponsor audits, prepares answers to audit findings at trial level; supports the team to answer audit findings at site level.
• Participates, as needed, in bid defense meetings organized with potential sponsors in an effort to secure new projects for TRIO.
• Works closely with the VP, Project Management to define required process changes impacting the Project Management department.
• Participates in the revision of procedures involving the PM Department.

Qualifications: 

• Bachelor's degree as a minimum. Scientific background (Nurse, Scientist, Pharmacist,
  M.D.)

• Advanced proficiency in MS Office specifically in Word, Excel, MS Project and
  PowerPoint.

• At least 10 years of experience in monitoring or coordination of clinical projects.

• Oncology expertise (at least 5 years of experience working on clinical trials in oncology).

• Strong leadership skills to effectively manage multi-disciplinary teams.

• Excellent communication skills, both written and oral.

• Ability to present in public and to interact with sponsors.

• Ability to build project plans incorporating all key elements of trial conduct.

• Excellent knowledge of ICH/GCP.

What TRIO Can Offer You:  

• Competitive salary
• 3 weeks of vacation plus paid Christmas Closure
• 2 weeks paid personal/sick time
• 100% health benefits for you and your family paid by TRIO
• Flexible working hours
• Monthly internet allowance
• 401(k) Program 5% Salary Contribution
• Home office allowance

Pay Range: $155,000 - 200,000 USD - Salary to be influenced (or determined) by the education, experience, location, knowledge, skills, abilities of the applicant, internal equity, and alignment with market data.

All interviews are currently being conducted virtually - via phone or video. We thank all candidates for their interest; only those selected for an interview will be contacted.

Innovation • Teamwork • Passion •Integrity

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