Senior Clinical Data Manager

Job title : Senior Clinical Data Manager
Location : England
Job type : Permanent
Salary : £50000 - £60000 per annum + Annual bonus
Contact name : Yanick Millet
Contact email : yanick.millet@secpharma.com
Summary of key responsibilities :

- Leading the Clinical Study Team from the study design.
- Overseeing and closing collaboration with study team members as well as cross functional stakeholders, through effective communication and proactive identification of opportunities as well as risks, management and mitigation to ensure timely and on-budget execution of clinical trial deliverables
- Ensuring the conduct of studies in accordance with Regulatory Authorities, company SOPs and ICH-GCP guidelines including Trial Master File (TMF) Management, ensuring inspection readiness at all times.
- Perform risk assessment and develop risk mitigation strategies to support study delivery
- Effective management of vendors to the required standards
- Lead/support global process development and improvement activities
- Travel as required to support the execution of clinical studies as required


Basic Qualifications :

- BA/BS/BSc or RN
- Global clinical project management experience
- Experience in oversight of external vendors (e.g. CROs, central labs, imaging vendors, etc.)
- Broad experience working in life sciences or medically related field, including general biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company)
- Knowledge of time, cost and quality metrics, Key performance indicators (KPIs)


Preferred Qualifications :

- Extensive clinical research experience working in life sciences or medically related field, including general biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company)
- Experience in innovative trial design, adaptive trial design
- Experience in Oncology is preferred but not essential


Key Competencies for the role:

- Ability to lead and work effectively in a global team/matrix environment on multiple projects
- Analyze data to identify trends and patterns to support mitigation activities/actions
- Critical thinking and horizon scanning
- Problem solving
- Informed decision making
- Relationship Management and influencing skills
- Good prioritisation and time management
- Organizational and planning skills
- Strong IT skills to manage internal systems and reporting