Clinical Trial Manager
Parexel
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇮🇹 Italy
Visit company websiteJob Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- Manage external vendors and contract research organizations
- Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual
- Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents
- Assist with protocol development and study report completion
- Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols
- Provide guidance, direction, and management to CRAs
- Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities
- Coordinate study supplies
- Negotiate contracts with vendors of clinical trial services
Requirements
- Bachelor’s, nursing degree or equivalent required, science preferred
- 5 or more years of industry experience in global clinical studies (Pharmaceutical, Biotech or CRO)
- Proven track record with relevant clinical trials experience, including strong performance as a CRA in the pharmaceutical industry (i.e. biotechnology, pharmaceutical, CRO, medical device)
- Proven experience of clinical trial management
- Experience in CNS and / or oncology is preferred
- Proven management/leadership of people in a matrixed environment
- Management of global clinical trials
- Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations
- Demonstrated ability to work independently and in a team environment
- Travel required. Must be willing to travel 15-25%, including international travel
- Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)
- Excellent oral and written communication skills and strong organisational abilities
Benefits
- Professional development opportunities
- Open and friendly work environment
- Opportunities to develop long-term careers
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial managementprotocol developmentsource data verificationmonitoring activitiespatient enrollment trackingdata management coordinationcontract negotiationGCPICH guidelinesFDA regulations
Soft skills
leadershipcommunicationorganizational abilitiesindependent workteam collaborationguidance and directionmanagement in a matrixed environment
Certifications
Bachelor’s degreenursing degreeequivalent degree