Senior Biometrics Project Manager - Latin America

The Bioforum Project Management office is growing, and we have an opportunity for an experienced Biometrics Project Manager to join our group. This position is inLatin America (South America).

Skills:

• Excellent interpersonal and written and spoken English communication skills, with the ability to effectively interact with clients, internal teams, and stakeholders at all levels.

• Solid general understanding of clinical trial processes, including biostatistics, medical writing, and data management practices, with expertise in at least one functional domain.

• Proficiency in project management tools and software.

• Proven ability to manage multiple projects simultaneously while maintaining high standards of quality and attention to detail.

• Effective critical thinking skills.

• Strong organizational and time management skills.

• Problem-solving skills and the ability to adapt to changing project needs.

• Experience with budget planning and management.

• Experience in client management and a demonstrated ability to build and maintain strong client relationships.

• Strong leadership and team management abilities, with a track record of successfully leading cross-functional teams.

Knowledge:

• In-depth knowledge of biometrics processes, including statistical analysis, data management, and clinical trial reporting.

• Solid understanding of clinical trial documents (protocols, statistical analysis plans, CRFs, study reports) and processes.

• Solid understanding of regulatory guidelines (ICH-GCP) and industry standards.

• Strong knowledge of office software (Microsoft Office).

Prior experience (6+ years) in project management within the biopharmaceutical industry or CRO setting. Significant experience in at least one biometrics functional domain is preferred. Functional leading experience can be considered in lieu of direct project management experience.

Key responsibilities:

Project Planning and Initiation

• Collaborate with stakeholders to define project scope, objectives, and deliverables.

• Develop detailed project plans, including timelines, budgets, resource requirements, and risk mitigation strategies.

• Lead in project kick-off meetings, ensuring clear communication of project objectives, scope, and expectations to all stakeholders.

• Identify potential risks, issues, and discrepancies, and ensure mitigation strategies are created.

Cross Functional Collaboration

• Contribute to Business Development by participating in bid/proposal development and participating in bid defense meetings.

• Facilitate communication and collaboration among cross-functional teams, including data managers, biostatisticians, programmers, medical writing, and clinical operation staff.

• Coordinate and facilitate regular project team meetings to monitor progress, address issues, identify and mitigate risks, and ensure effective communication.

• Act as main point of contact for internal- and external clients, providing regular updates on project status, milestones, and potential risks.

Project Execution

• Lead execution of biometrics projects according to established project plans, including tracking budgets, scope, milestones, timelines, and deliverables.

• Assist in the management of project risks and issues, implementing mitigation strategies as needed.

• Collaborate with the Biostatistics and statistical programming teams to ensure accurate and timely statistical analysis of clinical trial data.

• Collaborate with Data Management to ensure accurate database design, data collection and data cleaning activities throughout the duration of the clinical trial.

• Collaborate with the Medical Writer to define clear objectives, timelines, and deliverables for the development of study protocols, IBs and CSRs.

Quality Assurance

• Ensure that all biometrics deliverables adhere to company SOPs, industry standards, and regulatory guidelines.

• Oversee the implementation of quality control processes for biometrics activities.

• Contribute to updates to PMO SOPs and WIs under the direction of senior department team members.

Client Communication

• Serve as primary point of contact for client interactions related to biometrics project updates, status reports, and issue resolution.

• Prepare and deliver regular project status presentations to internal and external stakeholders, highlighting key milestones, risks, and mitigations.

Documentation and Reporting

• Maintain accurate and up-to-date project documentation, including project plans, meeting minutes, and correspondence.

• Generate project-related reports and metrics to monitor project performance and ensure transparency.

• Ensure timely and appropriate filing of project documentation in the Biometrics Trial Master File

Continuous Improvement

• Identify opportunities to optimize biometrics processes, streamline workflows, and enhance the efficiency of project execution.

• Collaborate with the PMO and other departments to share best practices and lessons learned to improve overall project management effectiveness.

Mentorship and Leadership

• Provide mentorship and guidance to junior project management staff, fostering their professional development and growth.

• Lead by example, promoting a culture of excellence, collaboration, and innovation within the PMO.

Originally posted on Himalayas