Clinical Operations Manager

hace 5 días

Santiago de Chile MSD A tiempo completo

The role is accountable for performance and compliance for assigned protocols and sites in a country. Under the oversight of the CRA manager the person ensures compliance of study conduct with ICH/GCP and country regulations, our policies and procedures, quality standards and adverse event reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall responsibility of allocated sites.

Responsibilities include but are not limited to:

- Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
- Performs clinical study site management/monitoring activities in compliance with regulations, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
- Gains an in-depth understanding of the study protocol and related procedures.
- Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
- Participates & provides inputs on site selection and validation activities.
- Performs remote and on-site monitoring & oversight activities using various tools to ensure: o Data generated at site are complete, accurate and unbiased. o Subjects’ right, safety and well-being are protected.
- Conducts site visits including but not limited to validation visits, initiation visits, monitoring visits, close-out visits and records clear, comprehensive and accurate visit & non-visit contact reports appropriately in a timely manner.
- Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
- Communicates with Investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
- Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined Escalation Pathway as appropriate in collaboration with leadership as needed.
- Works in partnership with country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, headquarter functional areas and externally with vendors and Regulatory Authorities in support of assigned sites.
- Manages and maintains information and documentation in various other systems as appropriate and per timelines.
- Contributes to CRA team knowledge by acting as process Subject Matter Expert, buddy/mentor and sharing best practices as appropriate/required.
- Supports and/or leads audit/inspection activities as needed.
- Performs co-monitoring visits where appropriate.
- Following the country strategy defined by Clinical Research Director and/or Clinical Reseach Associates manager, contributes to the identification of new potential sites and works closely with them to develop strong clinical research capabilities.

CORE Competency Expectations:

- Fluent in Local Languages and English (verbal and written) and excellent communication skills, including the ability to understand and present technical information effectively.
- Excellent understanding and working knowledge of clinical research, phases of clinical trials, current GCP/ICH & country clinical research law & guidelines.
- Excellent understanding of Global, Country/Regional Clinical Research Guidelines and ability to work within these guidelines.
- Demonstrated ability to mentor/lead.
- Hands on knowledge of Good Documentation Practices.
- Proven Skills in Site Management including independent management of site performance and patient recruitment.
- Demonstrated high level of monitoring skill with independent professional judgment.
- Ability to understand and analyse data/metrics and act appropriately, also in a virtual environment.
- Experience with conducting site motivational visit designed to boost site enrollment.
- Capable of managing complex issues, works in a solution-oriented manner.
- Performs root cause analysis and implements preventative and corrective action. - Capable of mentoring junior CRAs on process/study requirements and is able to perform comonitoring visits where appropriate.

Experience Requirements:

- Min. 4Y of direct site management (monitoring) experience in a bio/pharma/CRO.
- B.A./B.S. with strong emphasis in science and/or biology

**Search Firm Representatives Please Read Carefully**

**Employee Status**:
Regular

**Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Hybrid

**Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Requisition ID**:R288040

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