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Study Delivery Manager

2 meses atrás

londrina, Brasil Tata Consultancy Services Tempo inteiro

Come to one of the biggest IT Services companies in the world Here you can transform your career


Why to join TCS? Here at TCS we believe that people make the difference, that's why we live a culture of unlimited learning full of opportunities for improvement and mutual development. The ideal scenario to expand ideas through the right tools, contributing to our success in a collaborative environment.


We are looking for (Pl/Sr Study Delivery Manager) who wants to learn and transform his career.


In this role you will:

Requirements:*


Works in close partnership with the Study Delivery Lead (SDL) on end-to-end operational study delivery activities, from study setup to study archival, with the focus on setting up, maintaining and ensuring completeness of internal systems / databases / tracking tools and project plans (CSAP);

Works cross-functionally, with internal and external partners, on clinical study management activities, as agreed with the Study Delivery Lead, for in-house and outsourced studies across all phases and therapeutic areas, in accordance with Study Team Operating Model (STOM), current clinical study regulations and GSK procedures, policies, best practices and standards, and plays a key role in successful study delivery, providing subject matter expertise across key processes and systems throughout the life cycle of the study.

University degree or equivalent, preferably in medical or biological science or discipline associated with clinical studies of relevant work experience in a pharmaceutical/scientific environment.

Knowledge of clinical trials, drug development process.

Excellent knowledge of ICH-GCP, clinical study delivery process, including regulations, operational best practices, industry standards. Well familiar with key systems used in clinical trial delivery. Experience in using Trial Master File industry accepted standard.

Strong project management skills (preferably with analytical / financial skills) and good leadership skills.

Excellent verbal and written communication in English.

Excellent communication and relationship building skills, including external service provider management skills

Excellent knowledge of, and skills in applying, applicable clinical trial regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines;

Ability to manage multiple competing priorities within various clinical studies with good planning, time management and prioritization skills;

Ability to think independently, analyze and solve problems systematically and creatively, and to take a risk-based approach;

A confirmed level of expertise and seniority within the area and function;

Logical / analytical thinking and an inclination to spot patterns and outliers. Quality mindset, critical sense, attention to details, effective training and mentoring skills.

Very good understanding of the principles of project planning and management;

Knowledge of project finance and accounting principles in order to understand budget, invoices, cross-charges and expense reports;

Excellent comprehension of Microsoft Office tools (Excel, PowerPoint, Word, Outlook, etc.). Knowledge of advanced Excel, timelines/budget tracking systems and clinical trial management systems;

Excellent stakeholder management and communication skills (oral and written), outstanding interpersonal skills.

Pharmaco Vigilance; ICH/GCP; Clinical Data; the Drug Safety and Regulatory process


What do we offer?

TCS Benefits – Brazil:

Health insurance

Dental Plan

Life insurance

Transportation vouchers

Meal/Food Voucher

Childcare assistance

Gympass

TCS Cares – free 0800 that provides psychological assistance (24 hrs/day), legal, social and financial assistance to associates

Partnership with SESC

Reimbursement of Certifications

Free TCS Learning Portal – Online courses and live training

International experience opportunity

Discount Partnership with Universities and Language Schools

Bring Your Buddy – By referring people you become eligible to receive a bonus for each hire

TCS Gems – Recognition for performance

Xcelerate – Free Mentoring Career Platform


At TATA Consultancy Services we promote an inclusive culture, we always work for equity. This applies to Gender, People with Disabilities, LGBTQIA+, Religion, Race, Ethnicity. All our opportunities are based on these principles. We think of different actions of inclusion and social responsibility, in order to build a TCS that respects individuality. Come to be a TCSer