Clinical Research Manager

About Alydia Health
Alydia Health is a venture-backed, clinical-stage medical device company dedicated to making childbirth safer for all mothers. Our technology has the potential to change obstetric care and reduce the mortality and morbidity associated with postpartum bleeding. Alydia has developed the Jada System, an investigational device designed to rapidly stop abnormal bleeding following childbirth. The Jada System is currently being evaluated in the U.S.-based PEARLE study which will serve as the basis for a 510(k) application to the FDA in 2020. Alydia intends to launch the Jada System in the US in 2020, with international expansion to follow.

We are a team of dedicated, mission-driven people, and as a small company, every team member at Alydia makes a big contribution towards our mission. We seek candidates who are passionate about improving healthcare and motivated to do the hard and exciting work required to bring a groundbreaking technology to market.

Primary Function of Position:

Reporting to the VP of Clinical Operations, the Clinical Research Manager will manage a fast-paced FDA IDE study with up to 20 sites in the United States. Future clinical trials may include IDE studies, single center studies, post-market registries, and other trials in the U.S. or global settings.

Candidates must have a demonstrated working knowledge of GCP, ICH guidelines, and FDA regulations and experience with all phases of a study (qualification through final study report generation). The successful Clinical Research Manager will have excellent problem solving and communication skills, and will demonstrate tactfulness and diplomacy in dealing with research customers and fellow team members.

Major Responsibilities:

• Manage and execute a highly complex study for a groundbreaking obstetrics device with the potential to save lives around the world.
• Effectively manage studies that enroll subjects in an emergent, fast-paced environment.
• Manage the in-house Clinical Research Coordinator including oversight of Trial Master File and audit-readiness.
• Manage monitoring report review and approval authored by CRAs.
• Develop creative clinical trial marketing materials and manage their inventory.
• Project development, execution & performance tracking (risk management, administration, financial management, budgeting and issue resolution).
• Set up and track documentation including clinical recruitment, subject status, documentationstatus and project status from clinical sites and/or CRO in excel and provide weekly reports for clinical team.
• Manage legal documents (vendor contracts, confidentiality agreements, site clinical trial agreements and budgets) through negotiation and execution.
• Coordinate internal and external conference calls including minutes and action item tracking.
• Work effectively with site study teams directly.
• Monitor clinical study data (remote and on site) according to monitoring plan, as needed.
• Develop clinical study investigational plans, case report forms, monitoring plans, tracking tools.
• Ensure regulatory compliance with company SOPs, FDA and ICH guidelines.
• Participate in clinical writing for FDA or other regulatory oversight.

Additional Responsibilities:

• Travel 20-40%, domestic travel.
• Support Vice President of Clinical Operations in ongoing projects.
• Support the company Quality Policy and Quality System.
• Support company goals and objectives, policies and procedures.
• Attend relevant clinical research professional meetings.
• Participate in recruitment / hiring of Alydia team members.

Level of Supervision Required:

• Open communication with VP and Alydia Health team with weekly meetings to establish nearand long-term goals and objectives.
• Largely self-directed with low level of direct supervision needed to achieve goals.

Preferred Experience:

• 10+ years of experience in clinical research role or medical devices/pharmaceutical clinical trials, as well as working in a cross-functional product development setting.
• Demonstrated management experience.

Preferred Education:

• Bachelor’s-level degree required. Degree in science/health/law related field (e.g., Biology, Nursing, Public Health, Biomedical, Law) preferred.
• Master’s-level degree preferred.

Preferred Skills:

• Excellent interpersonal, organizational, problem-solving, and written/verbal communication skills, confidence, and ability to work effectively with a wide variety of medical, research and administrative personnel within the company.
• Strong time-management and individual travel management skills.
• Professional interactions in office and with customers and vendors.
• Good documentation skills.
• Strong computer skills and electronic data capture experience.
• Ability to multi-task and prioritize with flexibility required in a start-up environment.
• Able to balance working independently and within a team on a variety of projects.
• Proficient in Microsoft Word/Excel/PowerPoint.
• Experience using Dropbox, DFExplore and Google G Suite (Gmail, Calendar, Drive).

Physical Demands:

The physical demands described here are representative of those that must be met by the employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essentials functions of the role.

Light work positions involving sitting, standing, and walking. Position requires ability to frequently exert 10 pounds of force to move objects, and occasionally exert up to 20 pounds of force to move objects.

Clinical Research Manager Job Description

Balance  Crouching   Kneeling   Lifting      Reaching   Talking   Standing
Feeling   Hearing       Grasping   Fine motor skills        Repetitive motion.

This job description in no way states or implies that these are the only duties to be performed by the employee occupying this position. Employees will be required to follow any other job-related instructions and perform any other job-related duties required by the supervisor.

Alydia Health is an equal opportunity employer and does not discriminate in employment or hiring practices on the basis of race, sex, age, handicap, religion, national origin or any other basis prohibited by law. All applicants should be legally entitled to work for any employer in the U.S.