Clinical Operations Manager Job at Parexel. Explore responsibilities, skills, qualifications, and application process for this key TMF role.
Clinical Operations Manager at Parexel – Full Job Details, Responsibilities, Skills, and Application Process
Parexel, a globally recognized leader in clinical research and regulatory services, is hiring for the position of Clinical Operations Manager – TMF (Trial Master File) at its Bengaluru location. This role is a critical part of Parexel’s Clinical Trials division and offers an opportunity to contribute directly to improving global healthcare outcomes through high-quality clinical research operations. Clinical Operations Manager Job at Parexel
Parexel is known for its commitment to innovation, patient safety, and operational excellence. The company believes in creating a meaningful impact by supporting the development of life-changing therapies. Every individual at Parexel, from research associates to leadership, plays a vital role in ensuring successful clinical outcomes. The Clinical Operations Manager position is designed for professionals who have strong experience in TMF processes, regulatory compliance, and operational oversight. Clinical Operations Manager Job at Parexel
If you are someone who is passionate about contributing to essential clinical operations, ensuring high-quality documentation, and driving process improvements, this role offers an excellent platform to grow your career in the global clinical research environment. Clinical Operations Manager Job at Parexel
About the Role
The Clinical Operations Manager – TMF will be responsible for supporting system and standards improvement activities within Parexel’s TMF operations. The role requires close coordination with internal teams, functional leaders, and project teams to ensure smooth implementation of TMF processes and compliance with global standards. Clinical Operations Manager Job at Parexel
The candidate will also provide backend operational support, contribute to strategic planning, and help develop efficient workflows that support client needs and organizational goals.
This position is located in Bengaluru, India, and is categorized under Clinical Trials, with the Job ID R0000036741. Clinical Operations Manager Job at Parexel
Key Responsibilities
1. Operational Excellence
The role requires maintaining a high level of quality in TMF processes and team deliverables. Key activities include:
- Reviewing the quality of TMF team outputs such as TMF overview documents, system steps, process compliance, and query quality.
- Identifying performance gaps and recommending remedial actions to improve quality and efficiency.
- Ensuring compliance with ICH guidelines, Good Clinical Practices (GCP), regulatory requirements, and internal Parexel SOPs.
- Participating in departmental and organizational improvement initiatives related to standards and systems.
- Coordinating with senior functional management to gather feedback and support process implementation.
- Supporting the development and maintenance of SOPs and tools in collaboration with Process Owners.
- Developing and updating job aids, training materials, and operational documents for TMF activities.
- Acting as an internal subject matter expert, offering guidance during project implementation.
- Handling routine administrative responsibilities such as timesheets, travel claims, and performance metrics.
2. Business and Financial Management
The Clinical Operations Manager will also contribute to business operations, helping projects run efficiently and within budget. Responsibilities include: Clinical Operations Manager Job at Parexel
- Providing consultation to project leadership on TMF strategy and performance.
- Supporting the collection and analysis of operational metrics to monitor progress.
- Creating action plans to ensure timelines and budgets are met.
- Assisting in the development of materials for TMF-related business opportunities.
- Maintaining internal libraries and repositories related to TMF documentation and business proposals.
3. Personal Ownership & Leadership
This role may include the responsibility of functioning as a senior subject matter expert (SME) within a project or specific account. Major tasks include: Clinical Operations Manager Job at Parexel
- Managing individual deliverables with a strong focus on quality, accuracy, and timeliness.
- Serving as a senior contributor on complex projects requiring deep TMF knowledge.
- Ensuring all assigned responsibilities meet Parexel’s operational standards and client expectations.
Required Skills
This role requires a combination of technical expertise, communication skills, and leadership ability. Key skills include: Clinical Operations Manager Job at Parexel
- Strong ability to manage multiple tasks and deliverables effectively.
- Excellent written and verbal communication skills, including the ability to present at meetings, conferences, and training sessions.
- Advanced client-focused approach to work and problem resolution.
- Flexibility and willingness to take on new responsibilities and learn new processes.
- Excellent time management and workload prioritization skills.
- Ability to work efficiently in a matrix environment and collaborate with cross-functional teams.
- Strong negotiation, networking, and stakeholder coordination abilities.
- Analytical and problem-solving abilities for handling complex TMF-related challenges.
- Ability to guide, mentor, and support team members and relevant stakeholders.
Knowledge & Experience Requirements
Candidates should have:
- Substantial experience in Trial Master File (TMF) coordination, documentation management, and clinical operations support.
- Knowledge of clinical research processes, regulatory requirements, and global clinical documentation standards.
- Experience working with clinical trial stakeholders, investigators, regulatory teams, and cross-functional project teams.
Educational Requirements
Candidates must be educated to a degree level in:
- Biological Sciences
- Pharmacy
- Health-related discipline
OR
Should possess relevant clinical or business qualifications that support the TMF and clinical operations domain. Clinical Operations Manager Job at Parexel
Why Join Parexel?
Joining Parexel means becoming part of a global organization dedicated to advancing clinical research and improving patient outcomes. Parexel offers: Clinical Operations Manager Job at Parexel
- Opportunities to work on international projects
- Exposure to cutting-edge clinical research technologies
- A collaborative work environment guided by empathy and purpose
- Professional growth through leadership, training, and skill development programs
- A culture focused on innovation, quality, and continuous improvement
If you aspire to grow in clinical operations and want to work with an organization that values excellence and patient-centric innovation, this role offers an excellent career pathway. Clinical Operations Manager Job at Parexel
How to Apply for the Clinical Operations Manager Position
To apply for the Clinical Operations Manager – TMF role at Parexel, follow these steps:
- Visit the official Parexel careers website.
- Search for Job ID R0000036741 or the job title “Clinical Operations Manager – TMF”.
- Review the job requirements and ensure your profile matches the qualifications.
- Click on Apply Now to begin the application process.
- Create or log in to your Parexel careers account.
- Upload your updated resume, cover letter, and required documents.
- Submit your application and track the status through your dashboard.
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Note: This job information is sourced from publicly available official sources. We share it for reference purposes only and do not claim ownership of the job posting.
