Associate Manager, Clinical Data Management

Associate Manager, Clinical Data Management

Cosa facciamo

A Kenvue, ci rendiamo conto dello straordinario potere della cura quotidiana. Costruiti su oltre un secolo di tradizione e radicati nella scienza, siamo la casa di marchi iconici, tra cui NEUTROGENA®, AVEENO,® TYLENOL,® LISTERINE,® JOHNSON'S® e BAND-AID® che già conosci e ami. La scienza è la nostra passione; la cura è il nostro talento.

Chi siamo

Il nostro team globale è composto da ~ 22.000 persone brillanti con una cultura del posto di lavoro in cui ogni voce conta e ogni contributo è apprezzato. Siamo appassionati di intuizioni, innovazione e impegno a fornire i migliori prodotti ai nostri clienti. Con competenza ed empatia, essere un Kenvuer significa avere il potere di avere un impatto su milioni di persone ogni giorno. Mettiamo le persone al primo posto, ci prendiamo cura di noi, ci guadagniamo la fiducia della scienza e risolviamo con coraggio - e abbiamo brillanti opportunità che ti aspettano! Unisciti a noi per plasmare il nostro futuro e il tuo. Per ulteriori informazioni, fare clic su here.

Role riporta a:

Global BioStats, Data Mgmt & Prog

Ubicazione:

Asia Pacific, India, Karnataka, Bangalore

Luogo di lavoro:

Ibrido

Cosa farai

Responsibilities will include but not limited to

• Plans and manages the design and implementation of Data Management tasks for complex human use research activities to successfully achieve strategic objectives

• Ensures all Data Management activities are conducted in accordance with high ethical and quality standards, all applicable GCP regulations and company procedures

• Coordinate with Data Management lead in the development of SOPs and other data management standards

• Collaborates with other functions such as Clinical and Biostatistics in evaluating and/or implementing opportunities to improve Data Management solutions

• Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects

• Responsible for end-to-end clinical data management activities and serves as a primary point of contact for internal and external study team members with some oversight from senior data management resources

• Provides strong quality and project oversight over third party vendor responsible for data management deliverables

• Takes a leadership role to gather content and integration requirements for EDC and close collaboration with partners supporting other data collection systems (eCOA, External Data)

• Enforces data standard conventions and quality expectations for clinical data per defined processes

• Contribute to the definition of data structure standards

• Authors, reviews/revises DM related study plans including Data Management Plan, Edit Check Specifications, eCRF Completion Guidelines and other study documents to ensure quality and standardization

• Chairs Data Quality Review meetings with cross functional study team members to ensure on-going review of clinical study data accuracy, quality and completeness

• Represents DM on cross-functional project teams & submission teams

• Provides support to Health Authority inspections and audits

• Represents Data Management on cross-functional project teams

• Evaluates proposals from external service providers

• Mentor junior professionals for skill set advancement

• FSP/CRO/Vendor Oversight: May act as core member of the study team and provides FSP/CRO/Vendor oversight for end-to-end Data Management activities, manages data currency throughout the trial, and overall monitoring DM deliverables according to the Service Level Agreement (SLA)

Required Qualifications & Core Competencies

• Bachelor’s Degree in Mathematics, Science or a related field required

• At least 8 years of clinical data management experience in healthcare related industry

• Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors

• Sound knowledge of all applicable regulations including CFR, GCP, ICH guidelines and industry standard practices regarding data management

• Proficiency with Clinical Data Management System required

• Strong project management; Exhibits expertise in metrics analysis and reporting methodologies

• Strong oral and written communication skills

• Communicate effectively with senior management and cross-functional teams

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