Principal Clinical Operations Consultant (eTMF Specialist)

NNIT is a leading global provider of IT services and consultancy dedicated to the life sciences industry. With a focus on delivering innovative solutions and ensuring regulatory compliance, NNIT empowers its clients to streamline their clinical operations and optimize their processes.

We are actively seeking a Principal Clinical Operations Consultant (eTMF Specialist) to join our team and contribute to our mission. You will play an important role in enhancing our team's capabilities and ensuring the success of our projects.

If you're enthusiastic about eTMFs and clinical operations, and you bring strong consultancy skills to the table, we invite you to consider exploring this exciting opportunity with us!

Role Overview:

As a Principal Clinical Operations Consultant with a specialized focus on electronic Trial Master File (eTMF), you will play a pivotal role in delivering strategic and operational consulting services to our esteemed life sciences clients. Your expertise in clinical operations, eTMF, Site Start-Up (SSU), and Clinical Trial Management Systems (CTMS) will drive the successful implementation of projects and solutions while adhering to industry best practices and regulatory requirements.

Key Responsibilities:

• Lead and contribute to the planning, design, and implementation of eTMF solutions, ensuring optimal document management and compliance throughout the clinical trial lifecycle.
• Provide subject matter expertise in Site Start-Up (SSU) processes and streamline procedures for efficient site activation.
• Collaborate with cross-functional teams to integrate eTMF systems with existing clinical trial technologies and databases.
• Lead client engagements and projects, managing timelines, budgets, and resources to ensure successful project delivery.
• Drive process improvement initiatives by identifying inefficiencies and proposing innovative solutions to enhance clinical operations and data integrity.
• Provide guidance and mentorship to junior consultants, fostering their professional growth and development.
• Collaborate closely with business development teams to respond to Requests for Proposals (RfPs) and contribute to business expansion efforts.
• Cultivate strong client relationships through effective communication, stakeholder engagement, and understanding of client needs.

Qualifications and Experience:

• Bachelor's or advanced degree in a relevant life sciences field or equivalent work experience.
• Minimum 10 years of experience in clinical operations, with a focus on eTMF implementation and management.
• Proven track record of successfully leading and delivering complex eTMF and clinical operations projects for life sciences clients.
• Extensive knowledge of Site Start-Up (SSU) processes, Clinical Trial Management Systems (CTMS), and their integration with eTMF systems.
• Strong understanding of regulatory requirements and industry standards related to clinical trial documentation and data management.
• Experience in responding to Requests for Proposals (RfPs) and actively participating in business development activities.
• Excellent project management skills, including the ability to manage multiple projects concurrently while ensuring quality and timeliness.
• Exceptional communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and communicate complex concepts to non-technical stakeholders.
• Commercial mindset with a proven ability to identify opportunities for upselling and cross-selling consulting services to clients.

Additional Information:

• This role may require occasional travel to client sites.
• NNIT offers a competitive compensation package, professional development opportunities, and a collaborative work environment.

What’s next?

If you are a driven and experienced Clinical Operations Consultant with a strong focus on eTMF and a passion for delivering exceptional consulting services to the life sciences industry, we invite you to apply and join our dynamic team at NNIT.

In order to ensure an efficient and fair recruitment process, we kindly encourage you to refrain from adding a photo on your CV. At NNIT, we are dedicated to conducting an inclusive recruitment process that offers equal opportunities to all candidates applying for our positions.

All candidates are encouraged to apply for the given job regardless of their gender, age, religious beliefs, sexual orientation, national and social origin, political opinion, disability, race, skin color, and ethnic origin.

Apply now and make your mark!