Job Description

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CATO SMS and Pharm-Olam, LLC have merged to form Allucent!

Allucent is a full-service contract research and development organization with international resources dedicated to helping pharmaceutical and biotechnology companies efficiently and expeditiously navigate the regulatory approval process in order to bring new drugs, biologics, and medical devices to the people who need them. Allucent is a non-laboratory environment. At Allucent, our mission is to help bring new therapies to light. When you work at Allucent, that means rolling up your sleeves and applying your scientific knowledge, clinical expertise, and experience to partnerships with our clients in small and mid-sized biotech companies

The TMF Lead is the Study TMF Manager and is responsible for End to end TMF Management activities for the assigned studies. TMF Lead is responsible for ensuring eTMF Inspection Readiness for all the assigned studies TMF which are conducted in accordance with ICH-GCP and applicable regulations.

• As a member of Global TMF Management, the TMF Lead is expected to Lead and contribute to process improvement with a focus on value to our business and meeting client needs
• To liaise with Global TMF Management staff and client team in order to fulfil job responsibilities and activities with supervision
• To obtain knowledge and skills to process study TMF documents in accordance with study requirements as per study-specific processes, Pharm-Olam SOPs/WIGs, GCP and regulations
• Lead and Execute the setup, Maintainence and close-out study TMF in eTMF system
• Primary point of contact for the assigned studies TMF and responsible for developing successful cross-functional relationships with internal and external stakeholders
• Drive Completeness, Quality and Timeliness of TMF content for all assigned studies until close out
• Effectively monitor and report on progress of the TMF to Internal and external customers
• Oversee TMF document flow within projected timelines
• Accomplish TMF activities in accordance with the contracted budget for Global TMF Management
• Develop and cultivate sponsor relationships through effective communication
• Primary point of contact for internal and external audits of study TMF-related queries and support the preparation of appropriate audit and inspection responses
• Apply lessons learned to continuous improvement of documentation management practices across study teams
• Provide feedback and guide Study Teams in order to build knowledge and awareness of good document management practices and TMF for clinical trials
• Assess impact of potential changes to TMF specifications prior to implementation; collaborate with study PM or designee if modifications are necessary
• Maintain Study Document Lists at the study, country and site levels by collaborating with all relevant Functional heads to ensure the placeholders are correctly and accurately in place for the study and all versions of documents are filed in a timely fashion
• Conduct periodic quality review of Study Document Lists at all levels and liaise with the Document Owners to ensure that all findings are addressed and remediated in a timely manner
• Participate in Company/Departmental initiatives, as requested.
• Other duties as assigned.

• Report to Manager/designee in Global TMF Management Department
• Collaborate with POI study teams, all Pharm-Olam staff and Client Team.
• Bachelor\'s degree (Life Sciences, Medicine, Pharmacy, Nursing, business administration, or related discipline) preferred, and/or combination of education and experience
• Prior experience in a contract research organization (CRO), pharmaceutical, or biotechnology company preferred
• Minimum of 6-8 years of Clinical Operations / Project Management expereince with eTMF Management experience for all regions
• Thorough and sound knowledge and strong working experience on eTMF/TMF files management
• Computer literate with experience in Microsoft Office suite.
• Good understanding of Pharm-Olam SOPs
• Good written and verbal communication skills
• Excellent interpersonal and organizational skills
• Ability to work independently and to effectively prioritize tasks
• Ability to manage multiple projects
• High level of Attention to detail.

Allucent