Clinical Study Manager Asia

BIOTRONIK is one of the leading manufacturers of cardio
- and endovascular implants and catheters for cardiac rhythm management, electrophysiology and vascular intervention. As a globally active company headquartered in Berlin, Germany, we develop, produce and distribute high-quality medical products based on the latest technology and research. Our success is based on the competence and results-oriented cooperation of our employees.

**PURPOSE OF THE POSITION**:

- To coordinate and perform all aspects of clinical trial management in the region
- To monitor BIOTRONIK sponsored studies according to BIOTRONIK’s SOPs
- To mentor and train clinical monitors in the region
- To manage research grants and investigator-initiated trials in the region

**ESSENTIAL JOB FUNCTIONS**:

- This is a regional role that combines leading the clinical staff in the region where present and direct monitoring in countries without local clinical staff
- Study projects cover all BIOTRONIK business units
- Site selection activities: contact potential investigators to discuss the proposed study and arrange pre-study visits
- Assist site and local clinical staff with ethics submission activities and contract negotiations.
- Answer any study-specific queries raised by site and local clinical staff.
- Complete Investigator Files with all appropriate documentation as per SOP (i.e. ethics correspondence and approval; CVs; regulatory approval; indemnity; signed financial agreement; etc.),
- Site Initiations: Conduct site initiation visits and following the visits, document activities in an Initiation Visit Report.
- Manage patient recruitment strategies in the region to ensure target patient numbers are met i.e. prepare study newsletters, advertising campaigns, investigator meetings etc.
- Ensure that Serious Adverse Events are reported according to SOPs and local requirements.
- Conduct all activities according to SOPs
- Participate in preparation and presentation of Investigator Meetings
- Arrange Monitoring visits at appropriate time intervals and document according to SOPs
- Follow-up and resolve any issues arising from Monitoring visits.
- Participate in global/local conference calls and meetings to review progress of ongoing trials as well as for training purposes.
- Track completed CRFs sent to Data Management/locked EDC forms; track issued and resolved data queries.
- Maintain in-house project files to ensure complete documentation, including all correspondence.
- Act as the key contact person for the project teams in Europe and the US
- Arrange Close-Out visits with sites and organize on-site or off-site archiving, document activities as per SOPs
- Mentor and train Clinical Research Associates in the tasks mentioned above across the region

**BASIC QUALIFICATIONS**:

- A University degree (minimum bachelor's degree or equivalent) in a health profession, medicine, science and/or engineering field
- At least three - five years' field monitoring experience working for a CRO, medical device or pharmaceutical company in the region
- Excellent clinical trial monitoring skills
- Strong working knowledge and understanding of FDA, ICH-GCP, ISO14155, and regulations governing clinical trials
- High level of attention to detail and strong organizational ability paired with excellent people skills

**EXPERIENCE**:

- Minimum 3 to 5 years of work experience as a Clinical Research Associate

**SKILLS AND COMPETENCIES**:

- Positive attitude
- Excellent communication skills both written and oral
- Attention to detail
- Accuracy and focus on quality
- Strong rapport building and communication skills
- Objective and outcome-oriented style, solution focus
- Computer skills (MS Office)
- Willingness to learn continuously
- Planning and organization skills, cost consciousness
- Presentation skills
- Willingness to travel in the region (estimated 50% of the time)

Location: Singapore

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.