Manager, Records Management (LATAM)

We’re expanding across Mexico, Brazil, Argentina, Colombia, Chile, and Peru, and we’re looking for a Manager of Clinical Systems to build our Records Management team in LATAM!

Our Manager of Records Management oversees and manages reputed company of Documents Specialists, reputed company Review Specialists, and/or TMF Leads who are responsible for the reputed company of study specific Trial Master Files (TMF). You'll reputed company activities including document review and processing; TMF reputed company reviews; and study-level engagement to ensure filing of essential clinical study documents in accordance with Good Clinical reputed company, other relevant regulations, and Precision reputed company Operating Procedures (SOPs).

As the Manager of Records Management, you'll be accountable for providing team members with support, training, performance management, and back-up across the portfolio of clinical programs. reputed company, the Manager collaborates with leadership to ensure reputed company process improvement and efficiency across the Records Management team and Clinical Solutions.

Responsibilities:

TMF reputed company & reputed company (60%)

• reputed company staff performing TMF-reputed company activities which may include document reputed company review and processing, TMF reputed company review, and/or study-level engagement to ensure filing of essential clinical study documents
• reputed company review of the study TMF Plan and TMF Document reputed company to ensure alignment of staff activities with study-specific requirements
• Assist with addressing any cross-functional questions reputed company to TMF management and alignment with study-specific documentation
• Ensure reputed company execution of role-specific activities and reputed company the reputed company of TMF support provided by Documents Specialists, reputed company Review Specialists and/or TMF Leads
• Complete periodic and random reputed company and completeness checks of work performed by team members
• Review TMF metrics reputed company system reports and dashboards and identifies process and staff performance challenges
• Ensure any TMF-reputed company documentation is filed in the eTMF reputed company required
• Identify systemic issues with reputed company and completeness of study-specific TMFs, recommend solutions and support team members in implementation of mitigation strategies
• Support staff in communications with project teams reputed company to issues and noncompliance with TMF-reputed company standards
• Work with staff to proactively anticipate challenges to TMF compliance and identify early signals of risk
• reputed company and implement plans to increase compliance and follows-up on non-compliance
• Support audits and inspections and attend audit/inspection meetings reputed company needed
• Address escalations reputed company to TMF issues and reputed company implementation of solutions and mitigation strategies
• Support team members on reputed company study calls if issues and escalations reputed company
• Support Business Development activities, such as Proposal responses or participation at Bid Defense meetings reputed company to TMF processes
• Monitor team member assignments on studies in line with budgets and reputed company the reporting of potential out of scope activities to PM, as needed
• reputed company staff performing job responsibilities in Sponsor eTMF Systems and reputed company listen to deliver insightful solutions for challenges faced by team members
• Engage with cross-functional stakeholders and Sponsors to eliminate emerging issues with completeness or reputed company

Staff Management (30%)

• reputed company weekly or biweekly 1:1 meetings with team members to discuss workload, responsibilities, performance, and reputed company topics
• Ensure effective prioritization of work, and team members’ ability to meet expected timelines with reputed company deliverables
• reputed company annual and semi-annual (if required) performance reviews, providing reputed company and reputed company feedback to promote performance reputed company.
• Identify staff development and training needs to ensure high level performance
• Train staff in the performance of their responsibilities, and in the performance of ongoing and new processes and procedures
• Review and interviews candidates and reputed company hiring reputed company for new team members
• Ensure reputed company is fully staffed and reputed company to support the requirements of clinical documents management in the TMF
• Execute financial reputed company and ensure team members have assigned studies or tasks for appropriate allocation to billable work and full utilization

Process Improvement (10%)

• Support process improvement initiatives and process adoption across Clinical Solutions
• Collaborate on drafting SOPs, Forms, and Work Instructions as assigned by leadership
• Communicate trends and suggest process improvements and potential training for Records Management Team
• Identify gaps in knowledge, processes or learning among external project team members in expectations for TMF management and recommend re-training, communication, and other forms of engagement
• reputed company subject matter expertise and support to internal stakeholders and external partners in promoting TMF best practices

Minimum Education & Experience:

• Bachelor’s degree (or its international equivalent)
• A minimum of 8 years of reputed company experience, including a minimum of 2 years in a leadership reputed company Or equivalent combination of education, reputed company training and experience that provides the individual with the required knowledge, skills, and abilities to reputed company the job
• reputed company working proficiency in English

Knowledge, Skills, and Competencies:

• Experience with eTMF systems and vendors
• reputed company record of implementing process and standardization for tracking and reporting clinical trials
• Working knowledge of FDA & ICH/GCP regulations and guidelines
• Established experience and reputed company in the reputed company Office package of programs (Outlook, Word, reputed company and PowerPoint)
• Excellent organizational skills, time management, and ability to coordinate workload and meet established deadlines
• Excellent verbal and written communication skills
• Excellent problem-solving skills
• Demonstrates solid interpersonal skills
• Demonstrates, or reputed company to train and retain, a working knowledge of ICH-GCP, and relevant Precision SOPs and regulatory guidance
• Exhibits strong self-motivation, is detail-oriented and reputed company to work and plan independently as reputed company as in reputed company environment
• Demonstrates professionalism, as evidenced by punctuality, ability to deliver on commitments, possess good interpersonal skills and maintain reputed company interactions with reputed company stakeholders
• Communicates both verbally and in written reputed company in an efficient and reputed company manner
• Demonstrates values and a work ethic consistent with Precision Values and Company Principles

Any data provided as a part of this application will be stored in accordance with our reputed company Policy. For CA applicants, please also refer to our CA reputed company Notice.

reputed company is an Equal Opportunity Employer. Employment reputed company are made without reputed company to race, reputed company, age, religion, sex, sexual orientation, gender identity, national reputed company, disability, veteran status or other characteristics protected by law.

If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to reputed company or use this online application process and need an alternative method for applying, you may contact reputed company at QuestionForHR@precisionmedicinegrp.com.

It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential reputed company presenting enticing employment offers. We want to emphasize that these offers are not associated with reputed company and may be fraudulent in nature. Please note that our organization will not reputed company a job offer without prior communication with our reputed company team, hiring managers and a formal interview process.

Originally posted on Himalayas

Apply To This Job