Clinical Trial Manager (Clinical Operations Lead)

Sweden, Solna (3 days per week) Sponsor-dedicated Permanent contract   

Syneos Health is looking for Clinical Trial Manager (Clinical Operations Lead) for big Pharma company located in Sweden. You are will be responsible for study oversight and delivery management (time, budget, quality) at country level from start-up to closure. 

Key Responsibilities and Major Duties:

• Coordinates country cross functional teams and acts as the main point of contact for a Country with the protocol manager and other global study team members
• Coordinates with other internal roles in country and site feasibility process, including proposal and validation of country study targets
• Develops country level patient recruitment strategy & risk mitigation.  Coordinates and ensures country level study enrolment targets and timelines are met
• Leads problem solving and resolution efforts including management of risk, contingencies, issue resolution and escalation to the appropriate stakeholder/s
• Assessment and set up the of vendors during study start up period (locally)
• Investigator Meeting participation and preparation 
• Ensures data entered in Clinical Trial Managements Systems is current and complete and access to eDC and vendor systems is available for the Country and clinical trial site personnel
• Validation of study related materials (i.e. protocol, ICF, patient material) 
• Responsible for preparing country specific documents (e.g. global country specific amendment)
• Prepares materials for Site Initiation Visits 
• Responsible for verifying and confirming with local team eTMF completeness (Country and Site level)
• Reviews Site Monitoring visit reports, takes action within the timelines specified and escalates issues and ensures appropriate documentation of issues.
• Coordination of database locks and query follow up.  Ensures timelines are met.
• Ensure inspection readiness of assigned trials within country.  Provide support to Health Authority inspection and pre-inspection activities
• Coordinates, develops and writes the Corrective Actions / Preventive Actions (CAPA) and ensures implementation for Country audit level findings. Drives CAPA review, implementation and completion.
• Lead  study team meetings locally
• Reviewing and approving payments (based on GOA) and manage patient compensation claims (if applicable)
• Management of Site relationships (includes CRO related issues
• May conduct Pre-Study Evaluation Visits (PSEVs) and Site Initiation Visits (SIVs)
• May perform site closure activities, including post-close out
• May act as point of contact for Sites
• May support preparing submissions to and obtaining approval from local Health Authorities, Ethics Committees and other relevant instances.

Requirements:

• Bachelors or Masters  Degree within life sciences or equivalent

• Minimum of 4 years' industry related experience

• Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives

• Thorough understanding of GCP, ICH Guidelines and Country regulatory environment

• In depth knowledge and understanding of clinical research processes, regulations and methodology

• Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management​

• Demonstrated organizational and planning skills and independent decision-making ability

• Strong organization and time management skills and ability to effectively manage multiple competing priorities

• Ability of critical thinking and risk analysis.

• Strong communication skills with a strong customer focus, able to manage both internal and external clients at all organizational levels

• Skilled in the use of technology

• Good verbal and written communication skills (both in English and local language).

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