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Clinical Trial Manager I - Sponsor Dedicated - Chile Home Based

0-2 years
Not Disclosed
10 Jan. 16, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Clinical Trial Manager I - Sponsor Dedicated - Chile Home Based

Updated: Yesterday
Location: Chile-Latin America - CHL-Home-Based
Job ID: 25001072


Description

Clinical Trial Manager

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our Clinical Development model puts the customer and the patient at the center of everything we do. We strive to simplify and streamline our work to make Syneos Health easier to work with and for.

Join our 29,000 employees across 110 countries who already know: Work Here Matters Everywhere.


Why Syneos Health?

  • Career Development: We focus on your career growth and progression.
  • Supportive Culture: Enjoy peer recognition, total rewards, and engaged management.
  • Inclusive Environment: Our Total Self culture lets you authentically be yourself.
  • Diversity and Belonging: We thrive by uniting diverse thoughts, backgrounds, and perspectives.

Job Responsibilities

  1. Oversee site management, clinical monitoring, and central monitoring to ensure patient safety, compliance, and data integrity.
  2. Support site interactions from activation to closeout, including patient recruitment and investigator payments.
  3. Identify risks in protocol execution and implement mitigations using strategic problem-solving.
  4. Ensure the clinical team understands contractual obligations and protocol requirements.
  5. Participate in and present at key meetings, such as the Kick-Off Meeting.
  6. Collaborate with cross-functional teams to meet study milestones like enrollment targets.
  7. Develop and maintain clinical study tools, including the Clinical Monitoring Plan.
  8. Oversee training for study teams on protocol specifics, SOPs, and other guidelines.
  9. Utilize dashboards and clinical trial systems to monitor progress and quality of deliverables.
  10. Ensure compliance with monitoring strategies and maintain inspection readiness.
  11. Provide feedback on site management documentation and ensure deliverables meet quality standards.
  12. Act as a liaison between the client and other functional departments regarding clinical deliverables.
  13. Assess team performance, address training compliance, and mitigate risks to study quality.

Qualifications

  • Bachelor’s degree or RN in a related field (or equivalent combination of education and experience).
  • Leadership skills to align teams and achieve milestones.
  • Clinical trial experience, preferably with risk-based monitoring.
  • Familiarity with Good Clinical Practice/ICH Guidelines and regulatory requirements.
  • Proficiency in budget management and financial principles.
  • Strong communication, presentation, and interpersonal skills.
  • Critical thinking and conflict resolution skills to manage risks effectively.
  • Willingness to travel approximately 20%.

About Syneos Health

In the last five years, Syneos Health has contributed to:

  • 94% of all Novel FDA Approved Drugs.
  • 95% of EMA Authorized Products.
  • Over 200 studies across 73,000 sites and 675,000+ trial patients.

We take initiative and embrace challenges to deliver in a competitive, ever-changing environment. Learn more about us!


Additional Information

Tasks and qualifications listed are not exhaustive and may be modified at the company’s discretion. Syneos Health is committed to compliance with all relevant legislation and equal opportunity employment policies.