Merck KGaA

Senior Specialist Clinical Trial Transparency

Posted On

Aug. 7, 2024

Location

Bangalore, Karnataka

Experience Level

D - Professional (4-9 years)

Job Type

full-time

Apply By

Jan. 28, 2025

Job Description

Your Responsibilities:May Lead activities and meetings, including compilation and distribution of materials, preparing agendas, meeting minutes etc.Participate in review and my develop CTT redacted documents (protocol, IB, CSR etc.)Assist in creating, editing, and distributing lay language summary, manuals, and other CTT documentsCreate, distribute, update, and maintain trackers, dashboards, or report for metric reportingSupport CTT activities with the functional team membersAssist study team with preparation for audits/inspectionsAssist with oversight of vendors, including review of vendor documents and invoices Coordinate and support the risk and issue management process Ensures strong oversight, review and delivery of trial/project CAPAs in order to meet corporate compliance standards and timelines. May support the development and implementation of department initiatives including input on SOPs, processes, and workstreams. May represents CTT within the Global Trial Team and serves as the key CTT operational point of contact for the trial for respective CTT activities Accountable for execution of respective CTT deliverable including definition of milestones. May also include clarification of project scope.Who you are:Minimum of 5 years in clinical research in a CRO, study site or Pharmaceutical/Biotechnology Industry (Clin.Ops, Medical Writing, Regulatory Affairs etc.). At least 4 years of knowledge and experience in clinical trial transparencyGeneral knowledge of clinical development, clinical operations and knowledge of the global registries for example Clinicaltrials.gov, CTIS etc.).Deep knowledge on the electronic disclosure system (Pharma CM)Emerging leadership competencies and influencing skills.Effective oral and written communication skills Proven team dynamic knowledge and skills and ability to foster partnerships across projects and multidisciplinary teams.Basic knowledge of drug development process, interfaces and interdependencies of clinical development with other functions (e.g., nonclinical & pharmaceutical development, regulatory, commercial/marketing)BS/BA in life sciences/healthcare-related discipline We are an equal opportunity employer that values workforce diversity. We want everyone to be able to bring their best self to work every day which is why equality and inclusion is at the forefront of all our activities. We are dedicated to a policy of non-discrimination in employment on any basis including race, caste, creed, colour, religion, sex, age, disability, marital status, sexual orientation, and gender identity.

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