Clinical Affairs Manager

Clinical Affairs Manager

This position is on-site at our Fulton Market office in Chicago, IL, and we are looking for good people who want to be a part of the amazing culture here at Alma!

Summary

The primary responsibility of the Clinical Affairs Manager is to drive the planning and execution of Alma’s Clinical Affairs activities in alignment with identified business goals and objectives. In this position, you will integrate your scientific and clinical knowledge to support the successful completion of clinical evaluations in compliance with investigational plans, applicable regulations, and Good Clinical Practice (GCP) standards and SOPs. We are seeking a­ Clinical Affairs Manager who is career-driven, has strong leadership skills, and a depth of experience in driving successful clinical teams.

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Manage the development and progress of Clinical Affairs activities and projects.
• Supervise research activities and study/evaluation sites to ensure adherence to protocols and study terms.
• Establish and maintain long-term collaborative relationships with clinical investigators, their research staff, and KOLs.
• Oversee the creation and maintenance of research activity records, which may include meeting minutes, data collection tools, reports, regulatory forms, dispensation records, consent forms, case reports, or others as needed.
• Contribute to medical writing and educational activities including abstracts, presentations, white papers, educational assets, the preparation of clinical documents, study design protocols, and others as needed.
• Other responsibilities as set forth by the Director of Clinical Affairs.

Competencies

• Demonstrated ability to plan, implement, manage, and complete multiple projects in a fast-paced environment.
• Strong analytic skills for strategic review and assessment of medical literature, clinical and statistical data interpretation and scientific study proposals and oversee data management activities.
• Exceptional oral and written communication skills including active listening, presentation, and interpersonal communication.

• Excellent organization, attention to detail, and ability to maintain detailed and accurate records.

• Proven capacity to manage up, down, and across internal and external stakeholders to produce desired outcomes, facilitate growth, and create value.
• Proactive, energetic, self-assured professional with personal integrity, the ability to develop healthy interpersonal relationships, and a desire for continual personal development.
• Ability to provide technical guidance and support to professional staff where needed.
• Ability to use positive influence and persuasion to motivate people effectively while building respect and rapport, including relationships with off-site clinical colleagues and staff.
• Ability to innovate and collate broad cross-disciplinary knowledge.

Education and Experience Required

• Bachelor’s degree in a scientific discipline; advanced degree preferred
• Clinical research certification highly desirable
• 5+ years’ experience managing clinical studies/activities
• Prior experience as a clinician or with energy-based devices is preferred

Skills Required

• Ability to manage time and resources to prioritize tasks and accomplish set goals efficiently
• Successfully navigate in a fast-paced environment with changing priorities and constraints
• Ability to collaborate, and contribute both as an individual and as a team member
• Strong problem solving, deductive reasoning, and decision-making skills
• Strong knowledge of Microsoft Office applications such as Excel, PowerPoint, Word, plus project management software, cloud-based systems, etc.
• Knowledge of medical device development, clinical trial/evaluation management, and the application of appropriate FDA, GCP, and ISO Standards to meet regulatory and compliance requirements

Supervisory Responsibility

This position has direct reports and will assist in mentoring and developing team members.

Work Environment

This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Travel

This position may require up to 40% travel as needed.

Work Authorization

Documentation showing eligibility to work in the United States will be required.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

Alma, Inc. is Equal Opportunity Employment:

We're proud to be an equal opportunity employer and celebrate our employees' differences, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or Veteran status.

E-Verification:

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.