Gilbert Meher are partnered with a high-growth, international Medical Device company in their search for a Clinical Project Manager.
The successful candidate will be joining a collaborative team in Texas, executing global clinical studies, whilst ensuring compliance to Good Clinical Practices (ICH/GCPs), Standard Operating Procedures (SOPs), and regulatory guidelines.
If you are interested in joining an award winning company, who are pioneering innovative medical technology to transform the lives of patients, this could be an ideal fit!
- Execute pivotal clinical trials in a timely manner, in accordance with company budget and quality expectations.
- Maintain professional relationships with investigational sites and KOLs, ensuring appropriate stakeholder engagement and support.
- Act as a point of contact for the applicable Regulatory bodies, ensuring the studies adhere to global/local regulations.
- Develop best practices to ensure projects are completed within the expected timeline.
- Effectively manage and oversee the study team’s performance.
- Interface with cross functional teams and manage internal relationships, opening lines of communication to meet projected trial timelines, trial execution and completion.
- Where required, manage clinical research/trial submissions, to regulatory bodies in full compliance with regulatory laws.
- Bachelor’s degree educated, ideally within medical/life sciences.
- 5 years executing clinical studies, ideally within the medical devices field.
- 2 – 3 years executing global feasibility, pivotal and post-approval trials.
- Sound working knowledge of all phases of clinical trial development, from concept through to Clinical Study Report.
- Knowledge of operational and regulatory processes involved with clinical trials.
- Technical writing and critical thinking skills, with a track record in designing and implementing projects at a global scale.
- Ability to manage diverse, global cross-functional matrix teams.
- Experience with budgeting and tracking of clinical trials, with effective management of resources to achieve successful results.
- Proficiency with EDC tools such as Medidata and Oracle Clinical.
- Knowledge of Excel data import/export management and descriptive data analysis.
- Must be willing to travel as required, including some international travel.
- 5 years’ experience with PMA Class III device process; experience with global regulatory processes also beneficial.
- Experience with various international clinical trials regulations.
- Professional certification for clinical trials management desirable.
- Ability to speak two languages would be highly beneficial (Spanish or Italian preferred)
For more information about this role, please contact Abigail Prudhoe at firstname.lastname@example.org or call +44 782 550 2645
Whilst we may not be able to respond personally to each applicant, we appreciate the time you have taken to consider and apply for a new role with us. If you have not heard from us within 4 weeks, then on this occasion your application has not been successful.