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Syneos Health

Compare

3.8

based on 576 Reviews

43 Syneos Health Jobs

Clinical Trial Manager II

Syneos Health

3.8

based on 576 Reviews

3-6 years

Kolkata, Mumbai, New Delhi + 4 more

1 vacancy

Clinical Trial Manager II

Syneos Health

posted 4d ago

Job Role Insights

Flexible timing

Key skills for the job

Problem Solving Communication Skills Acceptance Testing Conflict Resolution Presentation Skills Budget Management

Job Description

Responsible for site management oversight, clinical monitoring and central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatory compliance and data integrity

Oversees site interactions post activation through site closeout

This may include patient recruitment, investigator payments or other related activities

May be responsible for identification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT)

Reviews the study scope of work, budget and protocol content and ensures the clinical project team (CRAs/CeMs) is aware of the contractual obligations and parameters

Uses prior clinical experience, operational data, metrics and reports to identify risks to clinical trial management deliverables

Escalates to the project manager any risks to clinical trial management deliverables (timeline, quality and budget) and any activities and requests which are out of contracted scope

Employs strategic thinking and problem-solving skills to propose and implement risk mitigations

Participates and presents in key meetings such as Kick Off Meeting

Serves as an escalation point for communications with investigator site staff and may be required to interact on the phone or in person with principal investigators or other site staff members

This may include accompanying CRA team members to sites for observation or conflict resolution

Collaborates with other functional leaders such as Study Start Up, Patient Recruitment and Data Management to coordinate delivery handoffs and meet expected study milestones such as site activation targets, enrollment targets and database lock timelines

Reviews and provides feedback on other functional plans (eg

Data Management Plan, Communication Plan) as they relate to the clinical trial management activities

Responsible for development and ongoing maintenance of clinical study tools and templates, including the Clinical Monitoring Plan

Ensures CTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as needed

Ensures access and audit trail reviews are conducted as required

Coordinates initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study

Oversees resourcing allocations for CRAs and Central Monitors, site assignments and study team members' conduct, and identifies risks to delivery or quality

Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project and maintain proper visibility of its progress by the use of approved systems and / or tracking tools

Reviews the project oversight dashboards and other clinical trial systems (e g Clinical Trial Management System (CTMS), Electronic Data Capture (EDC), eDiary, Electronic Patient Reported Outcomes (ePROs), Trial Master File (TMF), IVRS/IWRS, Central Monitoring dashboards), to oversee site and patient activities, study team conduct and to ensure the data has been updated to reflect timely execution of all operational aspects (required visits/calls, duration, and frequency) according to plan

Understands the monitoring strategy required for the study and, where required, participates in the development of the study risk assessment plan

Is accountable for their assigned clinical team members' understanding, ongoing compliance and delivery according to the stated monitoring strategy, CMP/SMP, and risk plans

Reviews the content and quality of site and central monitoring documentation (site monitoring calls, site visit reports, site letters, central monitoring reports and pertinent correspondence), to ensure they represent site management activities and conduct and that they appropriately convey any risks to protocol/GCP compliance, trial conduct, patient safety or data integrity

Document requested revisions and approvals in CTMS

Ensures these deliverables are provided according to company and/or sponsor specifications, including delivery deadlines

Interacts with the client and other functional departments related to clinical monitoring, central monitoring and site management activities and deliverables

Provides status updates on the clinical deliverables and risks to clients, project management and leadership as per departmental or study agreements

Provides solutions for obstacles in protocol execution and site management

Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICH GCP and country regulations

This may include data management, study start up, patient recruitment, medical monitoring, pharmacovigilance and Quality Assurance (QA)

Supports Inspection Readiness for clinical trial management scope

Oversees CRAs and Central Monitors assigned to the study and routinely assesses study-specific process and training compliance, CMP compliance, and identifies emerging risks

Develop and support execution of corrective action plans at site and study level

Supports and completes activities to achieve data cut and lock deadlines

Provides feedback to line managers on staff performance including strengths as well as areas for development

May be assigned to larger, more complex trials

Qualifications

What were looking for

Bachelors degree or RN in a related field or equivalent combination of education, training and Experience Demonstrated ability to lead and align teams in the achievement of project milestones

Demonstrated capability of working in an international environment

Demonstrated expertise in site management and monitoring (clinical or central)

Preferred experience with risk-based monitoring

Demonstrates understanding of clinical trial management financial principles and budget management

Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements

Must demonstrate good computer skills

Good communication, presentation and interpersonal skills among project team and with sites

Strong conflict resolution skills

Demonstrated ability to apply problem solving techniques to resolve complex issues, and apply a risk management approach to identifying and mitigating potential threats to the successful conduct of a clinical research project

Demonstrates critical thinking to determine the cause and appropriate solution in the identification of issues

Employment Type: Full Time, Permanent

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What people at Syneos Health are saying

Clinical Trial Manager salary at Syneos Health

reported by 2 employees with 13-17 years exp.

₹18.4 L/yr - ₹23.6 L/yr

68% more than the average Clinical Trial Manager Salary in India

View more details

What Syneos Health employees are saying about work life

based on 576 employees

82%

95%

89%

96%

Flexible timing

Monday to Friday

No travel

Day Shift

View more insights

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