Clinical Research Manager - Overview of Clinical Trial Operations
This is a detail-oriented role that oversees clinical trial operations, including the preparation, assembly, and distribution of clinical trial documentation and reports.
The successful candidate will manage and maintain the paper trial master file (TMF) and electronic trial master file (eTMF) system, ensuring timely submission and archival of documents, completeness, and accuracy.
A key requirement for this role is to possess knowledge of clinical research processes, regulatory requirements, and good clinical practice (GCP).
Besides overseeing TMF systems, you will be responsible for organizing Compassionate Use documentation and pre-clinical study reports library.
The ideal candidate will have a Bachelor's degree in life sciences, healthcare, or a related field, with previous experience in a similar role preferably within a pharmaceutical or biotech environment.
Key Responsibilities:
* Preparing, assembling, and distributing clinical trial documentation and reports.
* Maintaining the TMF system.
* Conducting quality checks on the TMF system.
* Organizing Compassionate Use documentation and pre-clinical study reports library.
You will liaise with project managers, clinical operations, and other relevant team members to ensure the accuracy and completeness of clinical trial documents and reports.
What You'll Bring:
* Strong organizational skills to oversee multiple tasks and deadlines.
* Excellent communication skills to collaborate with cross-functional teams.
* Attention to detail to maintain high-quality documentation.
* Knowledge of clinical research processes, regulatory requirements, and GCP.
Why This Role?
This role offers a unique opportunity to work at the forefront of clinical research, overseeing the critical aspects of trial operations. If you are passionate about delivering high-quality results and working collaboratively with others, this could be the perfect fit for you.