Offer summary

Qualifications:

Bachelor's degree (Honors) required, Master's degree preferred., 4-9 years of related experience in TMF operations or clinical services., Proficiency in English and familiarity with TMF Reference Model and records management best practices., Thorough knowledge of ICH GCP and relevant regulations for clinical trials..

Key responsabilities:

Provide management oversight of TMF Management activities and personnel.

Act as a point of escalation for TMF related issues and communicate with study team members throughout the study lifecycle.

Coordinate and supervise the day-to-day work of TMF Operations staff, including training and mentoring.

Ensure continuous improvement in TMF practices and support department initiatives and strategies.

Job description

Provides management oversight of personnel and TMF Management activities for designated scope within TMF Operations. Responsible for end-to-end delivery of TMF services and collaborating with internal and external customers to ensuring delivery of high quality, timely service in line with corporate procedures, regulatory requirements, all applicable guidelines, and industry best practices. Act as coach and Subject Matter Expert within the department, aiding Managers in process improvements, issue escalation and training development and delivery. Support the alignment of activities and objectives of the TMF Operations groups with the organization’s core values, strategy and vision.

Project Support

Responsible for TMF Management for assigned studies and acts as point of escalation for TMF related issues and queries.

Communicate with study team members from study set-up through to TMF close-out and transfer/archival.

Lead TMF oversight discussions with stakeholders to optimize TMF management technology, processes, and standards and facilitate mutually beneficial resolutions.

Ensure TMF group meets timelines, provides high quality deliverables, complies with contractual project requirements for designated studies.

Study resource allocation (primarily within product line) in accordance with study scope and milestones.

Team Management and Engagement

Coordinate and supervise the day-to-day work of the TMF Operations staff assigned.

Train and mentor assigned employees on Alimentiv procedures and guidelines.

Guide and coach individual goal setting and professional development in alignment within the department and organization.

Responsible for performance management of direct reports including career conversations and oversight of work for quality and compliance.

Review and approval of line reports’ leave requests, expense reports and other administration.

Facilitate new team member training and onboarding.

Assist management with interview and hiring process.

Department Operations Support

Ensure continuous improvement through education, feedback, and guidance to TMF Operations and stakeholders to build knowledge and awareness of good document management and TMF practices for clinical trials.

Propose and collaborate on department initiatives and strategies.

Support with management of TMF archival responsibilities.

May work with other departments on special projects/workstreams to create solutions to address business and operational challenges.

May support Business Development activities related to TMF Management

Qualifications

MINIMUM EXPERIENCE REQUIREMENTS: 4-6 years of related experience

PREFERRED EXPERIENCE REQUIREMENTS: 7-9 years of related experience

MINIMUM EDUCATION REQUIREMENTS: (Honors) bachelor’s degree

PREFERRED EDUCATION REQUIREMENTS: Master’s degree

English language proficiency required

Additional Knowledge/Skills

Familiarity with the Trial Master File Reference Model and a demonstrated understanding of records management best practices

Demonstrated understanding of TMF documents (content/flow) generated by different departments

Possess a thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials and the management of TMF content

Leadership and/or teaching abilities and experience (preferred)

Cross-cultural work competency

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