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Merck

Compare

4.3

based on 307 Reviews

Video summary

118 Merck Jobs

Senior Specialist Clinical Trial Transparency

Merck Ltd

4.3

based on 307 Reviews

4-9 years

Bangalore / Bengaluru

1 vacancy

Senior Specialist Clinical Trial Transparency

Merck

posted 3d ago

Job Role Insights

Flexible timing

Key skills for the job

Cron Pharmacy Healthcare Clinical Research Medical Writing Operations

+ 2 more

Job Description

Senior Specialist Clinical Trial TransparencyLocation - Bangalore - Electronic City Your Responsibilities:May Lead activities and meetings, including compilation and distribution of materials, preparing agendas, meeting minutes etc
Participate in review and may develop CTT redacted documents (protocol, 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 Clinicaltrialsgov, 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 (eg, nonclinical pharmaceutical development, regulatory, commercial/marketing)BS/BA in life sciences/healthcare-related disciplineWork Mode: HYBRID