Job details

Clinical Study Manager

Release Date

19. Dec 2017

Place of work

Andover - United States

Functional area

Research + Development

Job Type

Full Time

Career Level

Manager without direct reports

Employment Type

Regular

Shift

No

Travel Required

No

About us

Straumann partners with passionate people who fit in with the agile dynamics of our size-for-success company. People at Straumann appreciate the opportunity to shape the future and create impact. Encouraging leadership and inspiring ideas from our people have guided us through our proud history of pioneering innovations.

Your tasks

    Position Summary:

    This position will be responsible for the management of clinical research for pre- and post-market objectives in the United States and Canada in accordance with FDA regulations, the ISO 14155 standard and current Good Clinical Practice. The position will report to the head of Clinical Research.

    Major Responsibilities of the Position:
    • Oversight of external clinical study team, including training and mentoring to ensure compliance to protocols, regulatory requirements, accepted clinical practice guidelines and ethical standards
    • Supervise clinical operations with regard to IRB approvals, site initiation visits, monitoring and site closeout visits and participate in same as necessary
    • Write clinical research protocols, informed consent documents, and CRFs
    • Assure studies and study sites achieve enrollment, subject follow-up, data integrity and study product management targets as well as compliance to study protocol and applicable regulations
    • Assist in the statistical analysis of data upon completion of studies as needed
    • Assist investigators with presentations and other post-study activities as needed
    • Manage the clinical research budget, including reconciliation of charges back to HQ
    • Oversee contracts and contractors including contract research organizations (CRO’s) as needed; displays firm approach in such interactions
    • Demonstrate strong organizational and problem-solving abilities in addressing and rectifying operational issues
    • Develop ongoing clinician relationships that facilitate open and dynamic communication
    • Maintains all records pertaining to clinical studies, ensuring compliance with relevant legal and corporate requirements
    • Remain current in the latest standards of clinical study conduct
    • Track issues of clinical operations importance

Your profile

    Minimum Qualifications:
    • Minimum of 4 to 6 years of clinical research experience (preferably in medical device trials)
    • Demonstrated clinical study management experience
    • Bachelors degree required, science field desired
    • Advanced degree desired
    • Experience in contributing to the design of study documents including but not limited to clinical protocols, consent forms, case report forms, site study manuals, and project/tracking tools
    • Knowledge of FDA regulations (21 CFR 812, 21 CFR 54, 21 CFR 56), GCP, and ISO 14155 international standards
    • Ability to travel up to 30%

    Required Knowledge and Skills:
    • Excellent interpersonal skills
    • Self-starter/initiator
    • External clinical research training desired