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(Senior) Clinical Trial Manager

Beacon Hill Pharma Cambridge ,MA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

 

Reporting to the Director of Clinical Operations, this individual will have primary responsibility for trial management within oncology or hemoglobinopathies indications. The successful hire will adhere to best practices ensuring rigor and high-quality execution of clinical trials from FIH through commercial marketing authorization. This person will manage cross-functional relationships with internal and external stakeholders and be the clinical operations representative to the respective program clinical sub-team. This individual will be hands on with trial sites fostering relationship development with KOLs. This is a high visibility position with great impact potential.

 

Responsibilities

•           Responsible for managing CROs/vendors for assigned trials ensuring adherence to defined scope of work and budget

•           Identify issues and implement solutions to ensure timelines are maintained

•           Develop and maintain tracking tools for clinical trials including study and monitoring visits, sample tracking, data entry and action item progress

•           Assist with the drafting of protocols, informed consent forms, study operations guidelines and other study plans

•           Develop trial specific training tools for site utilization

•           Oversee maintenance of the eTMF

•           Work with financial management to reconcile monthly actual and forecast budgets

•           Monitor and/or co-monitor clinical trial sites

•           Plan and coordinate advisory boards, investigator meetings and CRA trainings

•           Work collaboratively with supply chain to ensure seamless collection/manufacture/shipment of cells

•           Develop project-specific procedures and processes

•           Recommend and follow up on corrective actions

•           The candidate must maintain a high standard of professionalism, and confidentiality in this role and must be able to problem solve, communicate effectively, and trouble-shoot creatively

 

Minimum Qualifications

•           BS/BA/BSN – health/science related field preferred

•           Minimum 3+ 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.

•           Knowledge of industry standards as applied to ICH guidelines, GCPs and the CFR

•           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

•           5 or more years in a Clinical Operations Management role

•           Global trial management experience

•           Prior Clinical Monitoring and/or CRO experience

•           Knowledge of First in Human trial management

•           Experience with oncology and/or transplant

•           Experience with cellular therapy trial management

Company Description
Beacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations.

Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S.

Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.

Beacon Hill Pharma

Beacon Hill Pharma, Beacon Hill Staffing Group's Pharma specialty division, is a national staffing organization that provides contract, direct (permanent), FSP/outsourcing and consulting to pharmaceutical, medical device, biotech and contract research organizations. Beacon Hill Pharma places contractors in all 50 states by seamlessly coordinating recruiting resources in local and regional markets with Beacon Hill Pharmas National Recruiting & Delivery, a dedicated national recruiting team that focuses exclusively on national accounts, supporting regional recruiting operations and delivering contractors to all markets in the U.S. Whether start-ups or the Fortune 500, the public or private sector, Beacon Hill Pharma matches world class talent with exceptional opportunities.

Address

Cambridge, MA
USA