Manager / Senior Manager TMF

Emmes Group

9 - 13 years

10 - 15 Lacs

bengaluru

Posted:3 days ago| Platform:

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Skills Required

cro manager quality assurance gcp pharma resourcing clinical research ophthalmology continuous improvement operations auditing

Work Mode

Work from Office

Job Type

Full Time

Job Description

Lead day-to-day operations of the TMF team, ensuring compliance with SOPs, GCP, ICH, and applicable regulations
Supervise and mentor Leads, TMF Managers and Specialists, providing coaching, training, and performance evaluations
Oversee resourcing, workload management, and project assignments within the TMF group
Drive quality standards, ensuring timely CAPA resolution and effective audit/inspection readiness
Collaborate with cross-functional Clinical Operations teams to ensure consistent TMF processes and standards
Support training development and delivery for TMF staff, ensuring competency and compliance
Monitor operational metrics and ensure delivery against project timelines and sponsor requirements
Partner with Quality Assurance and PMO teams to address findings, mitigate risks, and implement process improvements
Provide input into proposals, budgets, and resourcing for new business opportunities related to TMF services
Represent TMF function in sponsor and internal project meetings, as needed Required Attributes Overview Emmes Group: Building a better future for us all
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients
Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma
Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience
We believe the work we do will have a direct impact on patients lives and act accordingly
We strive to build a collaborative culture at the intersection of being a performance and people driven company
We re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company
If you share our motivations and passion in research, come join us! Primary Purpose The TMF Manager/Senior Manager is responsible for leading and managing the Trial Master File operations team to ensure high-quality, compliant, and efficient delivery of TMF services across clinical projects
Reporting to the TMF Director, this role provides operational oversight, supervises TMF staff, ensures adherence to SOPs, and supports continuous improvement in TMF practices to meet sponsor and regulatory expectations

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