Job Description

Senior Clinical Trial Manager / Clinical Trial Manager II. Regional and/or Global experience. Bulgaria. Home- based roles

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

• ​The Senior ClinicalTrialManager(Sr.CTM)serves as the clinical functional lead, accountable for the delivery of site management, clinicalmonitoringand central monitoring of assigned study(ies)The position as defined by scope provides leadership, problem-solving, mentoring, and technical support to the Clinical Operations team to ensure compliance with the monitoring plan as well as ensures timeliness and quality of deliverables within the specified budget.The SeniorCTMmay providedirection,oversightand coordination ofCTM(s) working across regions and/or countries to ensure clinical project and site deliverables are met.

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  ​JOB RESPONSIBILITIES

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  • ​Responsible for site management oversight, clinicalmonitoringand central monitoring deliverables with a focus on patient safety, protocol/GCP/regulatorycomplianceand data integrity.

  • ​Overseessite interactions post activation through site closeoutThis may include patient recruitment, investigatorpaymentsor other related activities.

  • ​Maybe responsible foridentification of critical data and process, protocol execution risks and risk mitigations related to completion of the Risk Assessment and Categorization Tool (RACT).

  • ​Reviews thestudyscope 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,metricsand reports toidentifyrisks to clinical trial management deliverables

  • ​Escalates to the project manager any risks to clinical trial management deliverables (timeline,qualityand 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 berequiredto interact on the phone or in person with principal investigators or other site staff membersThis 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, enrollmenttargetsand database lock timelinesReviews and provides feedbackon other functional plans (e.g.Data Management Plan, Communication Plan) as they relate tothe clinicaltrial management activities.

  • ​Responsible for development and ongoing maintenance of clinical study tools andtemplates, includingthe Clinical Monitoring PlanEnsuresCTMS, dashboards and other systems are set up and available for use by the clinical team, including overseeing user acceptance testing (UAT) as neededEnsuresaccess and audit trail reviews are conducted asrequired

  • ​Coordinates initial and ongoing training to the study teamregardingprotocol specificities, Case Report Form (CRF) completion, dashboards, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, dataplansand timelines for the study

  • ​Oversees resourcing allocations for CRAs and Central Monitors, siteassignmentsand study team members' conduct, andidentifiesrisks to delivery or quality.

  • ​Ensures quality of the clinical monitoring, central monitoring and site management deliverables within a project andmaintainproper visibility of its progressby the use ofapproved 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), TrialMaster 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, whererequired,participatesin the development of the study risk assessment planIs accountable for their assigned clinical team members' understanding, ongoingcomplianceand 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 CTMSEnsures 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 deliverablesProvides status updates on the clinical deliverables and risks to clients, projectmanagementand leadership as per departmental or study agreementsProvides solutions for obstacles in protocol execution and site management.

  • ​Demonstrates understanding of other functions' roles in achieving compliance and delivery according to protocol, SOPs, ICHGCPand country regulationsThis may include data management, study start up, patient recruitment, medical monitoring,pharmacovigilanceand 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, andidentifiesemerging risks. Develop and support execution of corrective action plans at site and study levelSupports 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 trialsor may coordinate clinical activitiesfor a team of CTMsacross a portfolio of projects

  • ​May coach and mentor CTMsregardingfunctional clinical delivery, evaluation of project risks, and action implementation

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  ​QUALIFICATION REQUIREMENTS

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  • Bachelor’s 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.

  • Demonstratedexpertisein 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

  • Mustdemonstrategood computer skills

  • Strong conflict resolution skills

  • Demonstrated ability to apply problem solving techniques to resolve complexissues andapply a risk management approach toidentifyingand mitigating potential threats to the successful conduct of a clinical research project.

  • Demonstrates critical thinking todeterminethe cause andappropriate solutionin the identification of issues

  • Moderate travel may berequired, approximately 20%

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.