Senior Clinical Project Manager (full-time contract position) Aegerion Pharmaceuticals, Inc.
THIS JOB HAS EXPIRED Position Description
The Clinical Project Manager is responsible for the oversight of two Phase I studies being conducted at a Phase I unit in the USA. These studies have been requested by the EMA as a Post Assessment Measure. Specifically, this individual is responsible for directing all aspects of these clinical trials to ensure delivery of study data on time, within budget, and in compliance with SOPs and FDA and ICH/GCP guidelines. In addition, the Clinical Project Manager is responsible for input and planning of operational aspects of other clinical programs, specifically the pediatric program.
Coordinates efforts of the project team within Aegerion and third party vendors
Manage the Phase I unit and other functional areas.
Implements and manages clinical timelines, milestones and strategy for the two Phase 1 study/ies
Assists with the design, planning and implementation of the pediatric program
Responsible for the management of services provided by preferred vendors
Manages any required updates of the study-related documents including, but not limited to study protocols, informed consent forms, study plans, etc.
Reviews study related materials including, but not limited to monitoring reports, team meeting minutes, etc.
Participates in and conducts visits and meetings with the Phase I Unit
Tracks study progress, including regulatory document collection, IRB documentation and enrollment, management of clinical supplies, safety, and deliverable timelines
Participates in the analysis, summary and reporting of clinical data for regulatory or scientific purposes
Provides review and approval of invoices from external vendors
May also be involved in other activities within the Clinical Operations group as requested, such as the development of clinical SOPs.
B.S. degree with a minimum of 6 years of clinical research experience, including a minimum of 3 years as clinical project manager, preferably in the pharmaceutical/biotechnology industry or within a Clinical Research Organization
Clinical study management, including CRA experience
Phase 1 experience
Vendor Management experience
Demonstrated ability to manage multiple projects with deadlines in a fast paced work environment.
Thorough knowledge of the clinical research process, FDA and other regulatory requirements that may impact global clinical studies as well as ICH and GCP guidelines
Conscientious, influential person with an outstanding work ethic and strong personal discipline;
Willingness and capability to handle multiple projects and responsibilities within time constraints
Excellent organizational, leadership and problem-solving skills
Excellent written and verbal communication skills
Ability to successfully work with minimal supervision
Ability to successfully manage and influence without direct authority
Ability to successfully work both within a team and independently
Global / international experience preferred
Pediatric experience in orphan diseases preferred
||Cambridge, MA |
THIS JOB HAS EXPIRED