uniQure

Clinical Trial Manager - Lexington, MA

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Active since 27-10-2017 Job category Pharmacy
Location Lexington, MA Level Professional
Educational level Bachelor / Graduate Employment type -
Hours 40 Salary Competitive
Place in the Organization:

The Clinical Trial Manager (CTM) is a member of the Clinical Operations Department. The Clinical Operations department is responsible for the management (planning, implementation, maintenance and close out) of the Clinical trials with a focus on the investigators (+ staff), regulations, compliance, timelines, data collection and review, and safety. There are approximately 10 employees in the department with some of the activities outsourced to Clinical Research Organizations.

The CTM may be either a global CTM or a regional CTM. Within the trial matrix structure, global CTMs will have overall responsibility of the trial, and the regional CTM will support by owning their region. The CTM is expected to proactively identify and resolve operational project issues and leads process improvement initiatives as required. The CTM will also have responsibility for managing any outsourced vendors within the trial structure.

Key result areas (major duties, accountabilities and responsibilities):

The Clinical Trial Manager owns a clinical study from “end to end”. A CTM may functionally serve as a “Regional CTM” who will own activity within a region for a clinical trial (e.g., USA or EU). Additionally, a CTM may function as the “Global CTM”, who will own the entirety of the project across regions. The functional role will be determined based on size and complexity of the project, but in all cases, the following are expectations of the role.

• Clinical Trial Execution

  • Leads and motivates the cross-functional team and project team meetings
  • Provides guidance and mentoring to project team members
  • Schedules, supervises, and delivers project(s) in accordance with, ICH-GCP, uniQure policies and SOPs
  • Ensures projects are conducted within timelines, budget, scope and quality
  • Conducts risk and issues management and applies proper issue escalation
  • Ensures quality by defining and executing quality control steps
  • Uses metrics and reporting for managing the project
  • Serves as the primary project contact for communication and coordination for uniQure, third-party vendor(s) and project needs
  • Informs and manages stakeholders with the appropriate Clinical Trial information
  • Responsible for thorough preparation, startup, coordination and closure of Clinical Trial activities and deliverables
  • Ensures submission and approval by relevant Ethics Committee(s) and other local bodies (except clinical trial application(s))
  • Vendor Management


• Vendor Management

  • Drives processes for outsourcing to CROs, and other third parties vendor(s)
  • Builds strong relationships with individuals and groups to identify opportunities for sharing of best practices and to align activities and process where appropriate.
  • Interacts frequently with external partners, including expert panels, physicians and investigators, CROs, contract laboratories, advisory committees, clinical trial consultants, and where appropriate, cross-functional counterparts from development partner(s).
  • Primary point of contact for external vendors and partners


• Clinical Trial Strat Up and Close Out

  • Contributes to the development of study protocols and CRFs
  • Ensures the development of clinical trial related documents, e.g. patient information’s, case report forms (CRFs)
  • Conducts Study feasibility and ensures proper site selection and setup
  • Ensures all sites are properly closed out by the CRAs
  • Ensures that the TMF and ISFs are completed and meet regulatory standards.
  • Arranges for the proper archiving of the clinical trial documents
  • Communicates the closure / completion of the clinical trial to relevant internal and external stakeholder
  • Closes down all systems and tools used in the Clinical Trial

 

Qualifications & Skills:

  • Bachelor’s degree required; advanced degree preferred; medical related degree preferred
  • Strong interpersonal and communication skills.
  • Experience in and knowledge of conducting international Clinical Trials. Experience in complex clinical research projects and early drug development very desirable particularly within an orphan/rare disease therapeutic area.
  • Demonstrated leadership, communication, and organizational skills, along with problem solving, conflict resolution, and team building skills.
  • Detail and process oriented, with excellent project management skills, including risk assessment and contingency planning.
  • Knowledge of International guidelines and Regulations (e.g. ICH-GCP)
  • Read, write and speak fluent English
  • Excellent written, oral communication and presentation skills
  • Prior experience in the financial and/or Budget and Forecasting management of clinical trials is preferred
  • Diplomatic behavior
  • Proven excellence in cross-functional matrix and/or cross-cultural partnership setting

 

Core competencies:

  • Enthusiastic and proactive
  • Excellent problem-solving capabilities. Solution oriented.
  • Dealing with ambiguity, interpersonal savvy, perseverance
  • Informing and collaborative
  • Managing and measuring; PM mindset
  • Organizational Agility


More information
This listing is a full-time job

Job category Pharmacy
Industry / Industries Biotechnology
Region United States
Keywords Clinical Trials

Contact information

Name Jennifer Wagner

Location

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