Clinical Trial Manager (LATAM)

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Overview

The Clinical Trial Manager position at the Precision Medicine Group offers an exciting opportunity for professionals looking to advance their careers in clinical operations. This role is focused on overseeing clinical operations in several Latin American countries, including Brazil, Mexico, Argentina, Colombia, Chile, and Peru. As the position involves leading and managing clinical studies, it provides a chance to contribute to the expansion of clinical operations in a fast-paced, impactful environment.

Key Responsibilities

In this role, the Clinical Trial Manager will have several essential duties, including but not limited to:

• Acting as the primary clinical point of contact with clients, ensuring compliance with protocols and regulatory requirements.

• Collaborating with project managers to handle clinical budgets, including monthly invoicing and variance management.

• Developing clinical study documents such as clinical plans, informed consent forms, and study-specific manuals.

• Identifying training needs for Clinical Research Associates (CRAs) and third-party vendors, presenting at investigator and study kick-off meetings.

• Conducting feasibility analyses and driving site feasibility processes, which include generating potential site lists from key stakeholders.

• Developing and finalizing country recruitment and retention strategies based on feasibility analysis.

• Overseeing submissions to competent authorities and ethics committees to ensure compliance.

• Managing internal clinical meetings, setting expectations for CRAs and Clinical Trial Assistants (CTAs), and addressing site questions through an FAQ log.

• Developing and managing corrective and preventative action plans in collaboration with QA teams.

• Supporting business development and marketing efforts where appropriate.

Required Skills and Qualifications

The ideal candidate for the Clinical Trial Manager role will possess a combination of education, experience, and skills that include:

• A Bachelor's degree in a science or health-related field, with an advanced degree being preferred.

  

• A minimum of 7 years of clinical research experience, accompanied by significant clinical monitoring experience.

• Professional proficiency in English is necessary for effective communication.

• Strong skills in Microsoft Office products such as Outlook, Word, Excel, and PowerPoint.

• Exceptional communication and interpersonal skills to engage effectively with teams and clients.

• Excellent organizational skills, attention to detail, and a customer service-oriented demeanor.

• Willingness to travel both domestically and internationally, including overnight stays.

Competencies

The candidate should demonstrate mastery of relevant guidelines including ICH-GCP and a working knowledge of clinical management techniques and tools. They must possess proven experience in functional and project management, along with skills in risk management and change management.

Ability to foster team dynamics, plan effectively, manage risks, and lead teams while ensuring commitment to the highest standards of integrity and quality are crucial.

Salary and Career Growth Opportunities

While specific salary information is not provided, the role offers significant career growth opportunities. Clinical Trial Managers can expect to build teams, influence organizational culture, and take on broader project management responsibilities as the operations expand throughout the LATAM region.

Conclusion

For applicants seeking a dynamic and impactful role in clinical operations, this is an outstanding opportunity offered by Precision Medicine Group. The multiplicity of responsibilities allows for creativity and strategic thinking in the management of clinical trials across multiple countries. If you have significant experience in clinical research, a solid academic background, and are passionate about making a difference in the healthcare field, this position is ideal for you.

Your expertise could greatly influence the quality and success of clinical trials, ultimately impacting patient care and treatment options.

This job offer was originally published on jobicy.com