Merck KGaA Darmstadt Germany Looking for IT Project Manager – Clinical operations, GXP, Software Validation at Bengaluru, Karnataka Full Time

A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.

Job Title: IT Project Manager – Clinical operations, GXP, Software Validation

Role Description

The Clinical IT Project Manager provide the projects with agile and/or waterfall planning, execution management, governance, and reporting support. Responsible for the day-to-day management of large projects defining and managing scope, budget, timelines and quality, with full responsibility and authority to complete the assigned project. Defines project scope and leads the development, documentation and implementation of large-scale projects and change initiatives in line with organizational policies and strategies, defining and maintaining realistic project plans and monitoring progress against agreed quality and performance criteria.

Makes recommendations on strategies for improvement from the initial project engagement through to financial close. Facilitates requirements gathering sessions and documents functional requirements / specifications to capture business needs and validates and obtains sign off from business representative. Collaborate with PMO function in setting up new and improving existing project management office policies and processes.

Position will work with all levels of the business including business partners, technology teams, and key external vendors. Position will focus on managing projects implementing and supporting Clinical business solutions, including, but not limited to EDC, eTMF and CTMS. The clinical business areas of focus include Clinical Operations.

Key Responsibilities Include:
Setting project goals and coming up with plans to meet those goals

Maintaining project timeframes, budgeting estimates and status reports

Coordinating project team members (internal & externals) and developing schedules and individual responsibilities

Implementing IT strategies that deliver projects on schedule and within budget

Using project management tools to track project performance and schedule adherence

Conducting risk assessments for projects

Organizing meetings to discuss project goals and progress

Responsible for planning, prioritization, and implementation of deliverables, including implementations and operations.

Coordinate/Develop process documentation (current and to-be).

Interfaces with external vendors to manage the relationship and ensure the proper delivery of services.

Support in GxP Computer System Validation activities for IT, including implementation, validation, maintenance.

Collaborate with PMO group

Analyzing financial data, including project budgets, risks, and resource allocation.

Providing financial reports and budget outlines to Executives.

Support drafting new and improving existing project management office policies and processes.

Job Requirements

Must be comfortable to in Electronic city, Bangalore location with shift timings 1:30 pm- 10:30pm

Bachelor’s degree in computer science, Business Informatics or related disciplines required

Minimum of 6-12 years of experience

Experience managing medium to large projects end to end.

Experience collaborating PMO function of the organization.

Experience in working with software vendors for support and maintenance

Experience designing, deploying and maintaining cloud-based GxP applications

Experience with GxP guidelines, Computer Software Validation (CSV), and IT SDLC

Experience with Clinical Operational systems include but are not limited to EDC, eTMF Coding and CTMS is highly preferred

Project Management certification is a plus

Skills, Knowledge & Abilities:
Self-motivated and passionate to learn and adopt new technology and methodologies

Team-oriented and generous in sharing knowledge and enabling others

Reliable, consistent, and proactive

Capable of day-to-day problem solving and taking responsibility for decisions

Customer Service oriented with attention to detail and quality

Must be able to effectively prioritize and plan. Ability to address multiple projects and adapt to changing priorities.

Strong communication and facilitation skills to develop consensus, clarity, and decision-making

Ability to communicate and work independently with cross-functional/inter-departmental teams and within the framework of the IT organization.

Strong understanding and working knowledge of FDA 21 CFR Part 11, ICH E6

Experience working in a GxP environment(s) (FDA, EU, MHRA) is required

Experience supporting heavily outsourced organizations and working with CROs.

Proficient in Microsoft Project Plan, Word, Excel, PowerPoint and other applications.

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

Curious? Apply and find more information at https://jobs.vibrantm.com

Job Requisition ID: 245515

Location: Bangalore

Career Level: D – Professional (4-9 years)

Working time model:
Careers during Covid-19

Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by the Company. The Company uses the definition of “fully vaccinated” assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.

North America Disclosure

The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our Candidate Services team at 844-655-6466 from 8:00am to 5:30pm ET Monday through Friday. If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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