Clinical Compliance Consultant Sr Jobs

Assist in coordinating and communicating the results of consulting projects via written reports and oral presentations to management.

Adapts written, oral, and visual presentations to clients and management that encompass the use of infographic theory to augment templates.

Maintains knowledge and utilizes benchmarks and recent best practice research to engineering processes that are lean and efficient.

A minimum of seven (7) years of experience in senior-level healthcare leadership, nursing, and/or Consulting Services.

Provide executive and strategic consulting services aligning physicians and healthcare systems in partnership.

Ability to evaluate and determine strategic and operational opportunities in the market.

Minimum 2 years of industry experience

Comprehensive knowledge of registered and nonregistered products

Excellent communication skills (written and verbal)

Must be a self-starter, results-oriented, a team player and be able to prioritize responsibilities

Assist Managing Partner in Agent Supervision

Review incoming correspondence and handle red flags as appropriate

Any additional responsibilities or tasks that management deems appropriate as the role evolves.

Regular and timely communication of status to group management, customers, trading partners, and other members of the Liaison team

Experience with detailed business requirement gathering and creating functional specifications

10 years minimum experience as an Integration Analyst

Possess exceptional listening and both written and verbal communication skills

Experience with internet connectivity protocols (SFTP, FTP(s), HTTP(s), SMTP, etc...)

Collaborates with management to identify, evaluate, and recommend solutions to issues identified during performance of GMP audits.

Develops and provides meaningful metrics and trends to Management.

Follows instructions and responds to management direction; Takes responsibility for own actions.

Lead proactive evaluation and education of site GMP compliance against current and emerging regulatory trends.

Evaluate and manage proposed commitments to regulatory authorities/audit bodies in response to inspection/audit findings.

Complete other responsibilities, as assigned.

Document quality issues and performance measures for management review

Ensure compliance and understanding of quality requirements

Manage special projects and make recommendations as appropriate

Perform other duties and responsibilities as assigned

Excellent computer and presentation skills

Strong business development, organization, analytical and problem-solving skills

Clinical and product management experience that is customer focused (RN preferred)

Translate customer needs into functional requirements that drives action and provides sound direction to engineering, product owners and stakeholders

Develop and manage strong, collaborative relationships with associated product team and other stakeholders, as needed, to help drive results

Collaborate without cross-functional partners in operations, engineering, analytics, customer success, product and legal.

Collaborate with other VCS product owners on user stories and ensure cross team communication, outlining key dependencies and surfacing any risks.

Identify and evaluate activities that prioritize process improvements or gaps

Location: 100% Remote- must be willing to work EST Time Zone

any other skill set is added bonus

Extensive Cerner Build Experience- Required

Job Type: Full Time / Permanent

Work Authorization: No C2C or Sponsorship

Build in CCL Rules Development 70% and Adhoc 30%

5+ years of Global Pharmaceutical Clinical Study Management:

1) 10+ years of Clinical Research Experience:

Audit & Inspection Readiness Experience:

ADDITIONAL QUALIFICATIONS / NICE TO HAVES

1) GCP and Clinical Quality experience

Sr Consultant, Clinical Trial Compliance, Audit, & Inspection Readiness

Knowledge of clinical regulatory requirements such as experience with CMS and state regulatory and accreditation requirements preferred.

Makes recommendations to business unit partners for improvements or remediation to risk management, regulatory, and accreditation compliance programs.

Monitors business unit initiatives relating to the development and implementation of a risk management program for utilization management activities.

Collaborates with enterprise quality team, enterprise care management, and other clinical teams on regulatory initiatives.

Identifies opportunities to manage and mitigate those risks.

National +50 Miles away from nearest PulsePoint, National +50 Miles away from nearest PulsePoint

Knowledge of clinical regulatory requirements such as experience with CMS and state regulatory and accreditation requirements preferred.

Makes recommendations to business unit partners for improvements or remediation to risk management, regulatory, and accreditation compliance programs.

Monitors business unit initiatives relating to the development and implementation of a risk management program for utilization management activities.

Collaborates with enterprise quality team, enterprise care management, and other clinical teams on regulatory initiatives.

Identifies opportunities to manage and mitigate those risks.

National +50 Miles away from nearest PulsePoint, National +50 Miles away from nearest PulsePoint