Clinical Trial Manager

2 weeks ago

Singapore DN & ASSOCIATES EXECUTIVE SEARCH PTE. LTD. Full time

Our client is a Medtech startup that seeks to break the notion that physical wellness and exercise is to be enjoyed only by the young. They want to bring physical wellness and rehabilitation to senior folks - enabling them to enjoy the benefits of exercise, but without the stress or strain.

Building on the successful launch of their fitness and wellness devices, they are presently looking to unlock the medical potential of their devices for other chronic diseases. If you are a dynamic individual with experience in handling clinical trials and managing a team in a clinical setting, we would love to speak with you.

**Responsibilities**:

- Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.
- Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training.
- Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by company.
- Documents accountability, stability and storage conditions of clinical trial materials as required by company. Performs investigational product inventory.
- Serves as primary contact between company and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
- Performs study close-out visits per the study specific Clinical Monitoring Plan including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
- Assists with, and attends, Investigator Meetings for assigned studies.
- Authorized to request site audits due to data integrity concerns.
- Performs other duties, as requested.

**Requirements**:

- BA/BSc (or equivalent) in one of the life sciences or health care background (SRN) and a minimum of four (4) years of monitoring/site management experience is required.
- Strong knowledge of clinical research process, including working knowledge of all functional areas of clinical trials and medical terminology.
- At least four years of medical device trials experience.
- Experience in monitoring and/or coordinating clinical trials required.
- Excellent written and verbal communication skills to express complex ideas to study personnel at research and clinical institutions.
- Demonstrated ability to form strong functional relationships.
- Excellent, presentation, organizational and interpersonal skills.
- Ability to interact with all levels of staff to coordinate/execute study activities.
- Ability to handle several priorities within multiple, complex trials.
- Ability to reason independently and recommend specific solutions in clinical settings.
- Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer

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