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Bristol-Myers Squibb

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4.0

based on 129 Reviews

114 Bristol-Myers Squibb Jobs

Line Head, eTMF Specialist

BRISTOL-MYERS SQUIBB INDIA PVT.LTD.

4.0

based on 129 Reviews

5-7 years

Hyderabad / Secunderabad

1 vacancy

Line Head, eTMF Specialist

Bristol-Myers Squibb

posted 2d ago

Job Role Insights

Flexible timing

Key skills for the job

Project Management Analytical Chemistry Data Privacy GCP Clinical Trials Continuous Improvement

+ 4 more

Job Description

Manages the allocation of workload across a team of eTMF Specialists.
Oversees the upload and performance of quality reviews of electronic documents residing in the eTMF system to ensure they are inspection-ready and are compliant with the ICH/GCP and ALCOA Plus principles.
Training and overseeing that the team is accurately completing attributes/metadata/workflows as appropriate/required to documents uploaded, to facilitate classification, management, identification, and accessibility to retrieve files.
Actively manage and develop direct reports; ensure creation of annual objectives, completion of mid-year and end of year evaluations in accordance with company standards and timelines; oversee training on eTMF and other systems, procedural documents, and Health Authority regulations.
Prioritizes book of work for eTMF Specialists and assigns resources based on priority of projects.
Collaborates across multiple functions supporting clinical trial processes to ensure adherence to regulatory requirements for maintenance of compliant TMFs and identify efficiency opportunities.
Maintains continuous knowledge of the regulatory requirements and industry trends related to TMF compliance.
Communicate as appropriate with relevant stakeholders.
Leads and participates in continuous improvement initiatives related to clinical trial documentation and TMF compliance.
Address gaps in TMF compliance as highlighted by Quality metrics and KPIs
Undertake remediation/training where necessary to ensure eTMF documents meet user/requestor requirements.
Maintain the integrity of the departmental strategy and operating model by ensuring Quality Reviews follow the company s Standard Operating Procedures ( SOPs ), Directives, and industry best practice, and that assigned Quality Reviews are appropriately documented in the department s SharePoint trackers and other systems of record.

Minimum of a bachelor s degree in Life science, Business Administration, or equivalent experience. Advance degree a plus.

At least 5-7 years of experience in health sciences or related industry
Supervisory responsibility for eTMF, provides training, support, and coaching as required
Strong working knowledge of TMF, eTMF and clinical document management systems, preferably Veeva Vault eTMF.
Strong organizational and technical ability. Ability to create reports and dashboards in eTMF.
Demonstrated Excel, PowerPoint, and SharePoint skills.
Comprehensive knowledge of local and international regulatory guidelines/requirements pertinent to TMF Management.
Demonstrated ability to create/provide TMF related training and coaching to a broad range of stakeholders.

Extensive knowledge and application of ALCOA Plus standards, Good Clinical Practice, Good Documentation Practices, and International Council for Harmonization guidelines (ICH-E6)
Experience in directly managing, leading and developing employees, and collaborating with professional colleagues and peers
Subject Matter Expert knowledge of clinical trial documentation, TMF Reference Model, clinical trial activities and related terminology
Must have knowledge of Study, Country, and Site level essential documents.
Must be competent in Project Management tools and methodologies.
Excellent organizational and time management skills
Strong analytical, problem-solving, and critical thinking skills
Must be able to interact and communicate effectively at all levels of the organization.
Strong leadership and people management skills.
Ability to prioritize work and assess risk to meet the needs of the organization.
Adaptable and able to modify personal and organizational work style to meet the needs of the business.
Critical thinker: Utilizing an intellectually disciplined process of actively and skillfully conceptualizing, applying, analyzing, synthesizing and/or evaluating information gathered from, or generated by, experience, reasoning or communication that will be instrumental in the decision-making process for quality review
Highly motivated and passionate about continuous learning and organizational development.
Very strong communication and interpersonal skills, verbal and written, is required