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- Clinical Trial Manager - FSP / Sponsor Dedicated
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Clinical Trial Manager - FSP / Sponsor Dedicated
Parexel International Corporation
Southeast, Remote, United States of America
Primary Responsibilities:
- Acts as Global Protocol Lead. Serves as main point of contact for clinical site management.
- May act as mentor for less senior RCTO staff on the study.
- Supports Molecule Lead. Collaborates with internal team members, Contract Research Organizations (CRO), vendors and sites.
- Is the RCTO representative on the Clinical Study Team.
- Assists with design and review of protocols/informed consent forms (ICFs) and other study documents.
- Leads in identification, evaluation, and selection of clinical trial sites.
- Coordinates and manages vendor processes.
- Accountable for tracking of ancillary and investigational supplies, specimens and/or imaging.
- Facilitates communication between sites and Seagen cross-functional staff.
- Leads functional teams within Regional Clinical Trial Operations
- Conducts data review.
- Accountable for completeness of Trial Master File (TMF).
- Works closely with quality function to ensure inspection readiness. Supports audit and/or inspection activities.
- Primary point of contact for CRO activities.
- Ensures training compliance of all staff.
- Contributes to process improvement initiatives and departmental projects.
- Performs all duties and responsibilities in accordance with Code of Federal Regulations (CFR), International Council for Harmonization/Good Clinical Practice (ICH/GCP) Guidelines, SOPs, and other applicable guidelines.
- Must demonstrate high-level leadership skills and proactive communication. Ability to build, engage and energize the team and set high performance expectations.
- Ability to work successfully in an entrepreneurial and fast moving environment.
- Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training.
- Adheres to EP and Client SOPs and processes.
Education and Certification:
- Bachelor of Arts or Science (BA/BS) or equivalent or any relevant and qualifying training.
Skills and Experience:
- Minimum of 8 years of relevant clinical trial management experience.
- Oncology clinical research experience is preferred.
- Global Phase I-III trial Management experience.
- CRO management experience.
- Experience managing large teams (direct or dotted line reporting).
- Excellent leadership, communication, and organizational skills.
- Ability to proactively handle multiple tasks, manage a diverse range of functional activities and solve problems simultaneously.
- Strong communication and inter-personal skills.
- Highly responsive and proactive, a team player.
- Thorough knowledge of CFR and GCP/ICH requirements as well as European Clinical Trial Directive.
- Experienced in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint, Teams) and other clinical trial systems (eg, CTMS, EDC and eTMF).
Language Skills:
- Proficiency in written and spoken English.
- Proficient in local language (as applicable)
Other Requirements:
- Ability and willingness to travel.
Job posted: 2023-03-08