Clinical Research Project Manager
4 weeks ago
Job Title: Clinical Trials Operations Manager
Work Location: Uxbridge, London, UK
Work Structure: Monday to Friday, 37.5H/W. 3 days on site required
Contract Duration: 12-months
Pay Rate: £420 - £450
Position Overview:
We invite you to join i-Pharm Consulting as a Clinical Trials Operations Manager, where you will be instrumental in the global execution of Phase I - IV clinical studies across a range of therapeutic domains. Your role will ensure that clinical trials are performed in accordance with standard operating procedures (SOPs), company policies, and regulatory standards, delivering high-quality data for international product registration and commercialization.
Key Responsibilities:
- Oversee the management of small-scale clinical studies, including Phase I trials.
- Supervise the selection of contract research organizations (CROs) and vendors, managing their interactions and deliverables.
- Act as the primary operational liaison, overseeing site activities.
- Develop logistics and clinical study plans for trials.
- Manage timelines, documentation, and communications related to studies.
- Engage in project meetings with CROs, vendors, and cross-functional teams.
- Contribute to the development of SOPs and enhance project efficiencies.
- Review regulatory documents to ensure compliance.
- Assist in the preparation of safety, interim, and final study reports.
- Provide training to new or less experienced team members.
Requirements:
We appreciate diverse contributions and seek candidates with the following qualifications:
Minimum Education & Experience:
- PharmD / PhD with 2+ years of relevant clinical experience.
- MA / MS with 3+ years of relevant clinical experience.
- BA / BS / RN with 5+ years of relevant clinical experience.
- Experience in managing less complex studies and project teams, including oversight of external vendors.
Knowledge & Skills:
- Quick learner with the ability to adapt to change.
- Proficient in managing the full cycle of study management from initiation to closure.
- Advanced understanding of study management best practices.
- Comprehensive knowledge of FDA, EMA, and other national regulations, ICH guidelines, and GCP.
- Familiarity with standard medical and scientific terminology.
- Excellent communication skills, both clear and concise.
- Team-oriented approach in a highly matrixed environment.
- Ability to manage multiple tasks and travel as necessary.
If you are a dynamic and experienced professional ready to contribute to impactful clinical trials, we encourage you to explore this opportunity with i-Pharm Consulting.
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