Clinical Development Lead
Job Description
We are seeking a seasoned Clinical Project Manager to lead our cross-functional study team in the development and execution of clinical trials. As a Clinical Project Manager, you will be responsible for delivering trials with quality, on time, and within scope.
The ideal candidate will have a strong working knowledge of the clinical research process and applied knowledge of clinical project management methodology, processes, and tools.
Key responsibilities include:
1. Developing and executing local, regional, and/or global clinical trials using project management skills, processes, and tools
2. Partnering with other organizations to coordinate and actively participate in affiliate site and investigator training
3. Driving and coordinating local, regional, and global cross-functional study teams throughout study implementation, execution, and closure, empowering them to meet clinical trial deliverables, including issue management, contingency planning, and issue resolution
4. Being accountable for trial/regional enrolment strategy and execution, starting from country allocation through Last Patient Entered Treatment (LPET)
6. Identifying and assisting in developing continuous improvement activities based on important trends such as industry, regulatory, new technology, etc.
7. Managing TPO qualification process selection, and oversight
8. Accountable for ensuring a state of inspection readiness of the TMF records created, maintained, finalised, and owned by Clinical Development
9. Applying expertise and knowledge of global/regional regulations & Good Clinical Practice GCP and
10. Leveraging scientific and regulatory knowledge to prepare and/or provide technical consultation for clinical and regulatory documents, prepare for meetings with regulatory agencies, and draft responses to questions from regulatory agencies, TPOs, and affiliates
11. Combining scientific, regional, and operational knowledge as well as process expertise to impact clinical trial design, feasibility, and implementation
12. Utilizing clinical development knowledge, problem-solving, and critical thinking skills to support the scientific needs of the business
Required Skills and Qualifications
The ideal candidate will possess the following qualifications and skills:
* Bachelor's or University degree in a scientific or health-related field (preferred) or an advanced degree
* Clinical trial experience with a strong working knowledge of the clinical research process
* Applied knowledge of clinical project management methodology, processes, and tools
* Demonstrated ability to work cross-culturally with global colleagues and with TPOs
* Strong leadership and networking skills
* Effective and influential communication, self-management, and organizational skills
* Proficiency in the use of project management tools and techniques, e.g., Critical Chain, MS Project, MS Excel, MS PowerPoint
* Ability to travel periodically
Benefits
This role offers a unique opportunity to join a dynamic team and contribute to the success of our organization.
As a Clinical Project Manager, you will have the opportunity to work on challenging projects, develop your skills and expertise, and make a meaningful impact on our organization's success.
We offer a competitive compensation package, excellent benefits, and opportunities for professional growth and development.
Others
For more information, please contact us.