Job Description

OBJECTIVESPerform day-to-day management of CTMS and eTMF, including oversight of the review and approval of eTMF documents and generation of reports to measure completeness, accuracy, and timeliness of the eTMF, as per applicable regulations and guidelines, and Takeda requirementsAccountabilitiesLead the development of the study specific eTMF plans for assigned clinical studies.Perform quality control of documents submitted to the eTMF using the established acceptable criteriaEnsure clinical trial documentation is consistent with eTMF specifications, ICH-GCP guidelines, regulatory requirements, and applicable SOPsAddress eTMF questions pertaining to how documents are filed, and user questions related to the eTMF systemEnsure documents which fail TMF quality control and/or TMF quality review are effectively remediated and provide best practice recommendations, as neededEnsure Essential Document Lists (EDLs) are maintained on an ongoing basis.Monitor and identify study-specific eTMF trends and communicate to Clinical Operations and/ or other functional teams as neededAssist with inspection/audit related activities (e.g., preparation, correction action plans)Maintain up to date knowledge of the TMF Reference Model, industry best practices and regulatory requirementsSupport Clinical Operations Lead/ Clinical Operations Manager in performing CRO oversight as per agreed parametersCollaborate with study team leads to lead the set-up of studies, study teams and sites in the CTMS ensuring programs are configured according to the specific study requirements including countries and sites; grant access for internal and 3rd party vendor users; baseline expected deviation categories, study/visit plans, visit report letter templates and baseline milestonesManage end-user and group permission settings.Lead meetings to escalate trends, issues, and establish standards based on current industry standards, while problem solving and seeking appropriate endorsement across study teams and functions.Continually assess that CTMS features are functioning properly and efficiently; track all issues observations for future enhancement, bug fixes, or ongoing needs for training of CTMS features for continuous improvement of the management of the system.Education, Behavioural Competencies And SkillsMinimum Bachelors degree in science/healthcare field required3+ years of relevant clinical research and TMF experience at a biotechnology, pharmaceutical company or CRO requiredPrevious experience working in eTMF system software; experience in Veeva Vault CTMS eTMF system software preferredGood working knowledge of GCP and local clinical trial rules and regulationsOrganizational and problem-solving skillsSuperior communication, strategic, interpersonal, and negotiating skillsProven/ stable performance records over past 2-3 yearsTravel RequirementsDomestic travel may be required (20-30%), including some weekend commitments.Limited international travel (10-20%) may be required.Lifelancer ( ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech, data science and IT domains.Please use the below Lifelancer link for job application and quicker response.

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