Contract Clinical Study Manager - REMOTE job in City of London, England

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Job type: Contract

Discipline: Project/Study Manager (CSM/CPM), Program Manager / Director, Clinical Scientist

Location: United Kingdom

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a Contract Clinical Study Manager for a global biotech company. This is on a contract basis with the opportunity to work remotely in the UK.

As the Study Manager you will be accountable for day-to-day study Operations study execution and related deliverables and is the primary point of contact within Global study operations for a study.

Job Responsibilities:

Overall study execution oversight
Provide leadership, guidance and direction to study staff assigned to study
Responsible to facilitate and lead cross functional teams/sub teams as needed. May serve as an agenda driven member of the Clinical Development Team (CDT)
Collaborate with cross-functional study members to execute on study deliverables
Ensure cross-functional development of key study plans (e.g., monitoring plan, data management plan, safety plan, etc.)
Proactively identify and communicate Clinical Operations and cross functional study risks and mitigations; align with cross-functional Study Execution Team on overall Risk Mitigation Plan
Identify, manage, and escalate study risks, issues and opportunities that impact timeline, quality, and budget
Provide regular study quality and progress updates to key stakeholders as needed; monitor and act upon study metrics; review trend-identification and analysis and provide targeted follow up where appropriate
Collaborate with other Study Managers to ensure creation, consistency, and maintenance of the various study plans within a program
Collaborate with line managers of CTS staff to support team member productivity and career growth
Study protocol and Informed Consent Form (ICF) development
Study resource planning
Study timelines
Vendor oversight
Study start-up - site selection and activation
Drug / Investigational Product (IP)
Study quality
Study budget oversight
Recruitment, enrolment, and monitoring oversight
Study outcome and data deliverables
Study closeout
Insurance
Program-wide initiatives
- Lead or participate in study-specific projects that have a wider program impact
- Collaborate with study managers/cross-functional team members to identify and correct inconsistencies and implement consistent and best practices

Skills and Requirements:

Decision Making, Strategic Thinking, and Problem Solving
Influence and Organizational Awareness
Agility and Proactivity
Leadership
Communication and Collaboration
Data Analysis and Interpretation
Product and Therapeutic Area Knowledge
With advanced knowledge and experience in the following core and technical competencies:
Study Management and Execution
Compliance and Quality Data Analysis and Interpretation
Drug Development and Study Design
Product and Therapeutic Area Knowledge

If you are having difficulty in applying or if you have any questions, please contact Matthew Pike at +44 207 4400 639 or m.pike@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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