Clinical Trial Manager II (Client Base)
Location: India-Asia Pacific - IND-Home-Based
Job ID: 25003156
Updated: April 17, 2025
Description
Syneos Health® is a fully integrated biopharmaceutical solutions organization that accelerates customer success by translating clinical, medical affairs, and commercial insights into impactful outcomes. Our mission centers on simplifying and streamlining processes to improve the ease of collaboration and patient care. Join our team of passionate innovators and problem solvers who are committed to making a difference.
Why Syneos Health:
Career development and progression opportunities.
A culture that celebrates individuality and inclusivity.
A global team united by the desire to improve healthcare and change lives.
Job Responsibilities:
Oversee site management, clinical monitoring, and central monitoring with an emphasis on patient safety, regulatory compliance, and data integrity.
Manage site interactions from activation through closeout, including recruitment, investigator payments, and other relevant activities.
Identify clinical risks and mitigate them using the Risk Assessment and Categorization Tool (RACT).
Ensure awareness of scope of work, budget, and protocol content within the clinical project team.
Utilize prior clinical experience and operational data to identify risks to clinical trial deliverables and escalate any deviations to project managers.
Lead strategic problem-solving to mitigate risks.
Participate in key meetings such as Kick-Off Meetings and serve as an escalation point for site staff communications.
Collaborate with other functional leaders (e.g., Study Start Up, Data Management) to meet study milestones like site activation, enrollment, and database lock.
Develop and maintain clinical study tools, templates, and monitoring plans.
Coordinate initial and ongoing training on protocol specifics, CRF completion, and study plans.
Supervise CRAs and Central Monitors, ensure proper resourcing and quality deliverables, and identify risks to study delivery.
Conduct regular reviews of project oversight dashboards, ensuring timely execution of study activities.
Support risk assessment and monitor strategies, ensuring compliance with protocols, SOPs, and regulatory requirements.
Provide feedback and support to line managers on staff performance.
May be assigned to larger or more complex trials.
Qualifications:
Minimum 3 years of project management experience in clinical trials, from startup to closeout.
Preferably India-specific project management experience.
Bachelor’s degree or RN in a related field or equivalent.
Proven experience in site management and monitoring (clinical or central).
Knowledge of GCP/ICH Guidelines and regulatory requirements.
Demonstrated expertise in budget management and financial principles.
Excellent communication, presentation, and interpersonal skills.
Strong conflict resolution and problem-solving abilities.
Ability to apply risk management strategies to clinical research projects.
Moderate travel (approximately 20%) may be required.
Get to Know Syneos Health
Over the past five years, we have supported 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and conducted over 200 studies across 73,000 sites.
Join us in our commitment to creating better health outcomes.
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