Sr. Manager, Clinical Affairs

About Carlsmed                                                                                                                            

Our mission is to improve outcomes and decrease the cost of healthcare for spine surgery and beyond. The Carlsmed aprevo® personalized surgery platform is designed to improve the standard of care for spine surgery one patient at a time.

Position Description

Carlsmed seeks an experienced clinical affairs manager to oversee post market studies of surgical implants for adult spinal disorders.  The current primary project is the ongoing COMPASS™ multi-center post market observational registry.   COMPASS (Clinical Outcome Measures in Personalized aprevo® Spine Surgery) will follow up to 300 subjects for 2 years post-surgery.

Responsibilities

• Manage clinical study operations at 15+ study sites in the US.
• Daily field activities and communications with study sites (Principal Investigators, study coordinators), Institutional Review Boards (local and central IRBs), and in-house partners (Data Management, Medical Affairs, Accounting).
• Supervise clinical research associates to achieve project milestones.
• Oversee site onboarding, initiation/training, interim monitoring, and closeout.
• Support IRB submissions, patient enrollment, case report form completion and data queries.
• Create or update protocols and related documents (Case Report Forms, site and sponsor guidelines, site regulatory and subject binders, work instructions, monitoring reports, study agreements/budgets.
• Maintain electronic records including study-wide and site-specific documents.
• Administer electronic data capture (EDC) system for data entry by study site staff.
• Author study progress reports and monthly newsletters to study site staff.
• Review invoices from study sites and vendors.
• Support regulatory authority audits of study sites and/or sponsor as necessary.

Qualifications

• Minimum: Bachelor’s degree in life science
• Minimum 10 years clinical study experience
• Knowledge of spine surgery and/or orthopedics
• GCP trained and knowledge of FDA and ICH requirements
• Institutional Review Board submissions and related materials (protocol, ICF, CRFs)
• User/administrator of clinical Electronic Data Capture systems
• Available for domestic travel 5-10 days per month

Skills

• Excellent written communication skills, including reviewing and editing others’ work

• Strong computer software skills (MS Word, Excel, Outlook, PowerPoint, and Access experience)
• Strong communication and presentation skills

• Ability to manage subordinates while independently performing high quality work
• Continuous issue detection and resolution

Equal Opportunity Employer

Carlsmed is an equal opportunity employer.  All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.  Carlsmed is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know.

Compensation

We are pleased to provide a competitive salary and benefits. Our benefits reflect our investment in the overall health and well-being of our employees and their families. including paying 100% of monthly healthcare, dental & vision insurance premiums, a 401(k) plan with employer matching and unlimited PTO. The expected annual pay range is $130k to $165k. Compensation may vary based on related skills, experience, and relevant key attributes.