Clinical Trial Manager I/ II

Clinical Trial Manager I/ II 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 Remote
opportunity Looking for cdd with min 2yrs CTM exp Cdd with vendor management exp
preferred JOB RESPONSIBILITIES 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/Central Monitors) 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 (e.g. 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. May develop and support execution
of corrective action plans at site and study level. Supports and completes acti
vities to achieve data cut and lock deadlines. Provides feedback to line
managers on staff performance including strengths as well as areas for
development. QUALIFICATION REQUIREMENTS Bachelor’s degree or RN in a related
field or equivalent combination of education, training and experience Ability to
lead and align teams in the achievement of project milestones Capable of working
in an international environment Previous clinical trial experience in site
management Preferred experience with risk-based monitoring and clinical or
central monitoring Familiar with financial principles and budget management
practices 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 Basic conflict resolution skills 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 researchproject. Demonstrates critical thinking to determine the cause
and appropriate solution in the identification ofissues Moderate travel may be
required, 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. Discover what our
Syneos Health colleagues already know: work here matters everywhere. Work
alongside the brightest minds in the biopharmaceutical industry taking down
walls and removing barriers to speed our customers’ delivery of important
therapies to patients. We are strategic thinkers who actively seek different
perspectives, whether across offices or across oceans. Because we solve some of
the toughest challenges facing the most prestigious healthcare companies today,
you'll gain exposure and be supported with comprehensive resources including
emerging technologies, data, science and knowledge sharing. The diversification
and breadth of Syneos Health creates a multitude of career paths and employment
opportunities. We’re a growing, global company dedicated to advancing our talent
past their initial role. Discover what our 29,000 employees already know: work
here matters everywhere. We work hard, and smart, all in the name of getting
much-needed therapies to those who need them most. A career with Syneos Health
means your everyday work improves patients’ lives around the world. Selecting us
as an employer secures a career in which you’re guaranteed to: Partner with the
most diverse team of experts in the industry. From the top down, our people are
inspiring. Everyone has a voice and is encouraged to use it. Work in specialized
Syneos Health teams that are therapeutically or functionally aligned for expert
collaboration. We assemble clinical teams where everyone, from CRAs to senior
management, is skilled in the same therapeutic area or customer teams. With this
structure, everyone on your team speaks the same language and can deliver unique
insights into the therapeutic environment and patient population. We are
partners with purpose. We integrate seamlessly with our customers and do what’s
best for their success. Our people provide the brilliant ideas, valuable
insights and endless energy that accelerates the impact of life changing
therapies worldwide.