About this opportunity
Beacon Hill lists this Clinical Trial Manager opportunity in boston, Massachusetts. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Position Overview : Reporting to the Director of Clinical Operations, this individual will have primary responsibility for trial management for a first-in-human trial in both healthy volunteers and patients. This person will manage cross-functional relationships with internal and external stakeholders and be the primary driver of all clinical study related activities, timelines, actions and plans. This individual will be hands on with trial sites fostering relationship development with KOLs. This is a high visibility position with great impact potential.
Key Responsibilities:
Responsible for engaging third party vendors and managing the RFP process from vendor identification through bid defense and contracting
Accountable for managing CROs/vendors for assigned trials ensuring adherence to defined scope of work and budget
Facilitate dose escalation meetings and the associated content and documentation enabling them
Assist with the drafting of protocols, informed consent forms, study operations guidelines and other study plans
Work with finance to reconcile monthly actual and forecast budgets
Oversee maintenance of the eTMF
Perform co-monitoring visits of clinical study sites
Plan and coordinate advisory boards, investigator meetings and CRA trainings
Develop and maintain tracking tools for clinical trials including study and monitoring visits, sample tracking, data entry and action item progress
Maintain a high standard of professionalism, and confidentiality be able to problem solve, communicate effectively, and trouble-shoot creatively
Minimum Qualifications:
BS/BA/BSN – health/science related field preferred
Minimum 3-5 years’ relevant industry experience including at least 2 years of trial management experience
Excellent communication, writing and presentation skills
Demonstrated ability to work independently as well as in a team environment and seek resources as necessary
Ability to assess complex issues and propose viable solutions
Demonstrated ability to lead and organize team meetings
Ability to foster effective relationships with vendors, investigators and colleagues
Ability to contribute technical expertise to the various aspects of the clinical trial process.
Proficiency in study monitoring activities
Knowledge of the infrastructure and operational characteristics of CROs and centralized services.
Demonstrated effective time management skills
Must be willing to travel domestically and internationally up to 15-20%
Preferred Qualifications
MS or advanced degree
6 or more years in a Clinical Operations Management role
Prior Clinical Monitoring and/or CRO experience
Knowledge of First in Human trial management
Experience with dermatology indications
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Project Management
Waltham, MA $140,000.00-$155,000.00
#J-18808-Ljbffr
Worksite address
boston, MA, 02298, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.