Clinical Trial Manager II
Syneos Health Clinical
Remote
Job description
Clinical Trial Manager II - (22002504)

Description

Clinical Trial Manager II

Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.

Why Syneos Health
  • #SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.
  • We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
The Clinical Trial Manager II (CTM II) serves as the clinical functional lead, accountable for the clinical monitoring/site management delivery of assigned study(ies). The position as defined by scope provides leadership, mentoring, and technical support to the Clinical Operations team to ensure quality of deliverables and achievement of financial goals

Job responsibilities
  • Supports primary study Clinical Lead in routine reviews of Clinical Trial Management System (CTMS), Case Report Form (CRF), drug management, safety, Trial Master File (TMF), IVRS/IWRS enrollment, Data Visualization dashboards (where available) to oversee site and study team conduct, to ensure timely entry of all operational aspects (required visits/calls, duration, and frequency) according to plan. Oversees assigned site and study team members' conduct, and identifies risks to delivery or quality.
  • Ensures quality of the clinical 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.
  • 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 monitoring documentation (site monitoring calls, site visit reports, site letters, and pertinent correspondence), to ensure they represent site management activities and conduct. 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 and site management activities and deliverables.
  • Demonstrates understanding of other functions' roles in achieving site compliance and delivery according to protocol, ICH/GCP and or Good Pharmacoepidemiology Practices (GPP) and country regulations. This may include medical monitoring, Safety, Quality Assurance (QA). Supports Inspection Readiness for Clinical Scope.
  • Understands budgeted clinical activities in order to identify out of scope activities
  • Supports study tool and template development. Delivers initial and ongoing training to the study team regarding protocol specificities, Case Report Form (CRF) completion, Sponsor Standard Operating Procedures (SOPs), clinical plans and guidelines, data plans and timelines for the study.
  • Oversees assigned clinical staff routinely to assess site processes, perform review of all Source Documents and medical records, and perform Source Data Review (SDR) and/or Source Document Verification (SDV) per the CMP/SMP and reviews identified and newly emerging risks. May develop and support execution of corrective action plans at site and study level, in accordance with the risk based monitoring strategy outlined in the CMP/SMP. Supports and completes activities to achieve data cut and lock deadlines.
  • May evaluate staff’s competency to perform visits/site contact independently via sign-off visits and Performance Assessment Visits (PAVs) according to company standards and process.
  • Proactively engages in feedback opportunities that support BU level initiatives
Qualifications

What we’re looking for
  • Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
  • Demonstrates ability to lead and align teams in the achievement of project milestones, demonstrates capability of working in an international environment.
  • Demonstrates learning of basic clinical project financial principles
  • 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
  • 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
  • Moderate travel may be required, approximately 20%
As a healthcare company we have an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities, unless an exemption can be confirmed based on a medical condition or sincerely held religious belief. Submission & Approval of an Exemption does not guarantee that an exemption can be accommodated.

This job excludes CO candidates

Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.

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.

Primary Location: North America - US Home-Based
Job: Clinical Operations
Schedule: Full-time
Travel: No
Employee Status: Regular
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