Senior Clinical Trail Manager, Clinical Operations at Pharmaceutical Company in Massachusetts, Massachusetts, United States —
- Pharmaceutical Company
- Massachusetts, Massachusetts, United States USA
- 8/12/19 2019-08-12
Job ID: 136402
The Senior Clinical Trial Manager (Sr. CTM) drives the clinical trial execution activities for assigned clinical trials, and ensures trial deliverables are met according to timelines, budget, operational procedures, quality standards, GCP, SOPs and business guidelines.
· Leads cross-functional trial execution team to ensure delivery of complex clinical trials and manages protocol execution.
· Oversees CROs and vendors to ensure timelines, goals and deliverables are met with quality within budget and in accordance with SOPs, GCP and all applicable laws and regulations.
· Provides input to the clinical development plan and operational aspects of the clinical trial protocol (e.g., develops and/or reviews operational plans for trials).
· Identifies and/or anticipates operational risks and mitigation plans within assigned clinical trials and escalates issues and recommends contingency plans to Director of Clinical Operations as necessary.
· Establish study milestones and ensure accurate tracking and reporting of study metrics, timelines, update of trial information in all trial databases and tracking systems.
· Provide monitoring oversight including authoring of oversight plan, reviewing monitoring visit reports and perform periodic oversight visits to sites and/or vendors to assess progress and compliance.
· Manage clinical trial budgets, providing ongoing financial reporting and projections to the finance group and facilitate the development of clinical trial agreements, insurance and other relevant documents in conjunction with legal.
· Ensure the Trial Master File (TMF) is maintained throughout the trial and performs inspection readiness checks throughout the lifecycle of the trial.
· Serves as functional area reviewer of global clinical / regulatory submissions.
· Present study status reports of operational execution activities to senior management.
· Provide study specific mentor and training for in-house Clinical Research Associate(s) and/or Clinical Trial Coordinator(s).
· Participates in operational process improvement initiatives (including, training, SOP review and development of work instructions/tools/templates).
· 6-8 years of clinical research experience at a Biotech/Pharmaceutical or CRO company, at least 3 years direct clinical study management experience working in a full service outsource model as a clinical trail manager or clinical project manager is required.
· Experience managing early phase drug development studies including; clinical pharmacology, DDI, food effect, health volunteer is a preferred.
· Oncology and Women’s Health therapeutic experience is preferred.
· Global Clinical Trial Experience and the ability to support more than one clinical trial is required.
· Good working knowledge of the international conference on harmonization (ICH) and good clinical practice (GCP) guidelines and other applicable regulatory guidelines required.
· Excellent communication skills, ability to build strong relationships with peers and cross functional team members and CRO/Vendor partners, experience mentoring clinical study staff and presenting to senior management is required.
· Excellent computer skills (Microsoft Office Suite, Project, Word, Excel, PowerPoint, Outlook; Electronic Data Capture Systems).
· Requires a BS or equivalent in the health or life sciences is preferred.
· Some travel will be required (10 -20% depending on project needs).