Clinical engineer Jobs in Durham, NC

Clinical Manager, Clinical Science, Cronos

Durham, United States of America | Home-based

The Cronos Clinical Science team provides scientific oversight and expertise to ensure the quality, consistency, and reliability of clinical outcome assessment data in global clinical trials. The team supports rater training and calibration, reviews assessment data, identifies and addresses measurement risk, and partners closely with Study Operations and Technology to promote standardized administration, regulatory compliance, and high-quality endpoints across studies.

As a Clinical Manager in the Cronos Clinical Science team, your responsibilities will include:

• Attend sponsor meetings, as required.
• Conduct protocol review.
• Develop rater training methodology.
• Develop rater training materials, as assigned.
• Oversight of Quality Control process, assignments, and completions.
• Process ownership.
• Provide guidance to more junior team members regarding sponsor interactions, clinical expertise, etc.
• Contribute to preparation of presentations for sponsor meetings.
• Supervision of direct reports.
• Provide feedback to clinical trial raters via calls and/or emails.
• Conduct reviews of clinical trial site data and make determinations regarding required interventions.
• Identify issues and trends in study data.
• Serve as the primary clinical representative for sponsor interactions.
• Develop intervention methodologies and supporting materials.
• Coordinate with Clinical Leadership and staff, as appropriate, to identify, track, and update clinical deliverables.
• Communicate directly with external vendors/clients, as required.
• Contribute to the development of Standard Operating Procedures and Work Instructions.
• Support Clinical activities, ensuring appropriate execution and tracking of activities related to the service/product.
• Effectively communicate Clinical Department and assigned service/product metrics to Clinical Leadership.
• Execute data preparation activitiesincluding cleaning, transformation, and validationand perform data analytics tasks appropriate to experience level.
• Utilize MS Office (Word, Excel, Outlook, Powerpoint) and SharePoint proficiently in execution of job tasks.
• Other duties as assigned.

Candidates interested in joining the team should have:

• Proven problem-solving skills.
• A self-starting mind-set with excellent team-based interpersonal skills with the ability to work independently with the full spectrum of our people.
• Strong computer skills and proficiency with Microsoft Office applications, including intermediate proficiency in Microsoft Excel required. Experience with PowerBI a plus.
• Ability to build strong business relationships and influence with key stakeholders at all levels within the business.
• Ability to rapidly assimilate multiple types of information from a variety of sources for effective decision making.
• Excellent written and oral communication skills including grammatical/technical writing skills.
• Excellent attention and accuracy with details.
• Ability to confidently communicate with and effectively present information to internal team.
• Must be able to work in a fast-paced environment with demonstrated ability to effectively manage multiple tasks and projects.
• Strong individual initiative.
• Strong organizing skills.
• Strong commitment to quality.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Minimum Required Education and Experience:

• Minimum of a Master's degree (MA/MS) in Psychology, Counseling, Psychiatric, Nursing or Social Work, or equivalent.
• Minimum of 5 years of experience with psychiatric or neuropsychiatric populations (e.g., schizophrenia, major depressive disorder, Alzheimer's Dementia).
• Minimum of 5 years of experience administering psychiatric assessments, ratings scales and/or structured clinical interviews.
• Demonstrated experience with training others on psychiatric assessments, rating scales and/or structured clinical interviews.
• Minimum of 3 years of experience with central nervous system (CNS) trials.
• Advanced English proficiency.