This position requires a candidate with extensive experience helping evidence generation strategy and execution of clinical studies.
The Clinical Study Manager-4 (CSM IV) role will develop and execute strategies for clinical and outcomes research studies to help regulatory approvals and key strategic evidence initiatives.
As a member of the Clinical Affairs team, this role will be accountable for working with key stakeholders to design and develop clinical protocols and execute clinical studies (pre-market or post-market studies), with minimal supervision.
The candidate will be required to work closely with clinical research associates (CRAs), clinical trial assistants (CTAs) and data management for the conduct and execution of the study, as well as with biostatisticians to review and interpret results of clinical studies, develop clinical study reports, or help the development of clinical publications.
During trial execution, the CSM will drive the progress of the trial during site selection, site start-up and through enrollment and follow-up.
The CSM will clearly provide guidance to the monitors about monitoring needs, and oversee compliance work on the study.
The CSM will also take a leadership role in external communication with investigators and study teams.

Requirements

Minimum advanced degree in a scientific/bioengineering field (M.S., Ph.D. or M.D.) with a minimum of 5 years of experience in clinical research, or Bachelor’s degree in a scientific/bioengineering field with a minimum of 8 years of experience in clinical research is preferred, or a minimum of 10 years of experience in clinical research with relevant training.
Previous experience implementing, helping and managing medical device trials
Significant knowledge of clinical and/or outcomes research study design
Proven experience in protocol and ICF development, writing clinical section(s) for regulatory submission
Proven experience in conducting literature searches, reviews and appraisal of the scientific data
Excellent ability to interact with physicians and other professionals inside and outside the company
Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations, fundamental knowledge of clinical research and monitoring requirements
Experience negotiating clinical research contracts and budgets
Must be able to work effectively on cross-functional teams
Must be able to travel 25-40% or based on business requirements
Must be able to manage multiple projects and/or manage different priorities
Proven communication, presentation and relational skills with high attention to detail and organization
Ability to learn quickly, tailor to shifting requirements, and self-educate on different surgical specialties as applicable to clinical projects (“Self-starter attitude”).
Ability to drive project team consisting of CRAs and CTAs and support management with relevant study updates.
Exhibits solid work ethic to help meet tight timelines or multiple projects when necessary with a problem-solving mindset.

Benefits

Health insurance
Paid time off
Professional development opportunities

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

clinical researchclinical study designprotocol developmentICF developmentregulatory submission writingliterature searchclinical trial managementGood Clinical Practice (GCP)clinical monitoringmedical device trials

Soft skills

communication skillspresentation skillsinterpersonal skillsorganizational skillsproblem-solving mindsetself-starter attitudeability to manage multiple projectsattention to detailcross-functional teamworkleadership