Clinical Trial Manager Full-Service With Experience In Usa - Home Based Latam

0-2 years

Not Disclosed

Remote - South America (Latin Americal)

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 Full-Service with experience in USA - Home-Based LATAM
Updated: January 14, 2025
Location: Colombia - Latin America - COL - Home-Based
Job ID: 25001160

Description

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

Our Clinical Development model places the customer and patient at the center of everything we do. We are continuously looking for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for.

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 accelerate the delivery of therapies because we are passionate about changing lives.

Discover what our 29,000 employees across 110 countries already know:
WORK HERE MATTERS EVERYWHERE

Why Syneos Health

Employee Development: We are passionate about developing our people, with career progression, supportive management, technical and therapeutic area training, peer recognition, and a total rewards program.
Total Self Culture: We are committed to creating an environment where you can authentically be yourself. Our diverse culture is the foundation that unites us globally and ensures we take care of our people.
Inclusive Work Environment: We continuously build the company we all want to work for by bringing together diverse thoughts, backgrounds, and cultures to foster a sense of belonging for everyone.

Job Responsibilities

Oversee site management, clinical monitoring, and central monitoring deliverables, ensuring patient safety, protocol/GCP/regulatory compliance, and data integrity.
Manage site interactions post-activation through site closeout, including patient recruitment and investigator payments.
Identify critical data, process risks, and implement mitigations to ensure completion of the Risk Assessment and Categorization Tool (RACT).
Review study scope, budget, and protocol content, ensuring clinical project teams are aware of contractual obligations and parameters.
Use operational data and metrics to identify risks to clinical trial management deliverables and escalate issues to the project manager as needed.
Propose and implement risk mitigation strategies through strategic thinking and problem-solving.
Participate in key meetings such as Kick-Off Meetings and serve as an escalation point for investigator site staff communications.
Collaborate with functional leaders to coordinate study milestones, such as site activation, enrollment, and database lock timelines.
Oversee development and maintenance of clinical study tools, including the Clinical Monitoring Plan, and ensure system setup and user acceptance testing (UAT).
Coordinate study team training on protocol details, CRF completion, SOPs, and timelines.
Oversee CRA and Central Monitor resourcing, site assignments, and study team conduct.
Review clinical trial systems and project oversight dashboards to ensure data integrity and operational execution according to the plan.
Ensure compliance with ICH GCP, protocol SOPs, and regulatory requirements across all study activities.
Provide feedback on staff performance and contribute to corrective action plans when necessary.

Qualifications

Bachelor’s degree or RN in a related field, or equivalent education and experience.
Demonstrated ability to lead teams and achieve project milestones.
Expertise in site management and clinical trial monitoring.
Preferred experience with risk-based monitoring.
Understanding of clinical trial financial principles and budget management.
Strong knowledge of Good Clinical Practice/ICH Guidelines and regulatory requirements.
Excellent communication, presentation, and interpersonal skills.
Conflict resolution and problem-solving skills.
Ability to apply risk management techniques to ensure project success.
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 in a highly competitive, ever-changing environment. Learn more about Syneos Health.

#LI-RR1

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Clinical Trial Manager Full-Service With Experience In Usa - Home Based Latam

Job Description

Description

Why Syneos Health

Job Responsibilities

Qualifications

Get to Know Syneos Health

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