Clinical Project Manager Sangart
THIS JOB HAS EXPIRED Description of Duties:
As a key member of the Clinical Operations team, you will participate in activities which involve the preparation for and implementation of global clinical trials. These activities include but are not limited to:
Contributions to the development and preparation of clinical documents (e.g., protocols, informed consent, amendments, case report forms, etc.)
Clinical site interactions (including site identification and feasibility assessment, monitoring, enrollment tracking, clinical trial material and clinical supply requests) in conjunction with the CRO
Interactions with the CRO at team meetings and independently to follow-up on observations
Interactions with other internal departments including Regulatory, Quality Assurance, Project Management, Manufacturing
Participation in Clinical Operations team meetings
Contribution to program plans
Review and comment on clinical trial data
Clinical trial and regulatory document tracking
Ability to provide training in GCP/ICH as well as protocol/therapeutic requirements.
Representing Sangart at meetings, conferences, advisory boards, and establishing relationships with physicians and medical staff who are interested in our clinical trials.
Preparation and review of protocols, amendments, consent forms, case report forms, and other trial related documents.
Management of external vendors, including CROs and specialty laboratories
Review of site visit reports and correspondence with trial sites
Monitoring and Co-monitoring activities at clinical study sites and laboratories to assure adherence to good clinical and laboratory practices, S.O.P.'s, protocols, and contractual specifications
Assist in the preparation and management of study budgets
Preparation of clinical portions of regulatory documents as required
Participation in clinical data reviews including periodic listings, tables, figures, safety reports, and researching data queries within the electronic data capture tools.
Preparation and review of clinical study reports
Develop and issue communications related to the conduct of clinical trials for site education and motivation
Travel to sites in area of responsibility to evaluate conduct of trial and provide training and support to site staff to supplement that provided by CRO.
Bachelor?s degree in a science or a health-care-related field.
10+ years of clinical research experience as a Senior Clinical Research Associate, Clinical Study Manager, or Clinical Project Manager is required.
Experience in challenging therapeutic areas such as critical care, trauma, emergency medicine, stroke, sepsis and/or brain injury a plus.
Proficient oral and written communication skills, and be detail-oriented with strong organizational abilities.
Self-starter who can operate with minimum direct supervision.
Ability to multi-task, be flexible, identify and solve problems, and thrive in a fast-paced environment.
Excellent interpersonal skills, with a demonstrated ability to work in an international team environment, are required.
Must be able to travel (international up to 50 % or more depending on timelines). This travel includes site visits as well as participation in major product related meetings where clinical data are presented.
Ability to communicate in English. Communication in other languages a plus.
||6175 Lusk Boulevard |
San Diego, CA 92121
THIS JOB HAS EXPIRED