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Job Title: Clinical Project Manager

Classification: Permanent

Travel: Yes, up to 25%

Position Summary: Clinical Project Manager will be responsible for managing multiple projects simultaneously to support the completion of tasks and deliverables. Additionally, the position is responsible to communicate cross-functionally, and with Sponsors, vendors, suppliers, contractors, sites, and upper management on project related activities.

Our ideal candidate is someone who thrives in a fast-paced and dynamic environment, and takes initiative to seek out information, knowledge, and development, proactively. They should be a resourceful problem solver who is savvy with technology and finds effective and efficient solutions to complex client problems. The Clinical Project Manager is a true self-starter who deals well with uncertainty and ambiguity. Lastly, they are a proven team player who puts the success of the team first.

Essential Duties and Responsibilities: We are looking for a detail-oriented clinical professional to join our growing Clinical team as a Clinical Project Manager to work closely with Clinical Operations and Clinical Affairs to ensure compliance with regulatory authorities.

This role will provide you the opportunity to coordinate and support key product development activities while gaining knowledge of product development. These responsibilities include some of the following:

• Details daily coordination, understanding and oversight of scheduled activities, considering responsibilities needed to carry out contracted work and compiling status updates on all projects deliverables
• Prepares professional communications and assist in the design of new tasks and projects.
• Coordinates and/or conducts investigations to resolve data discrepancies and reconcile data as appropriate
• Assist clients, collaborators, and senior management in the implementation of new projects and expanded work scopes
• Understands project scope including the creation of or supporting the Project Manager in compiling and maintaining project timelines, and attending internal and client meetings
• Preparation and submission of all required documents to internal and external stakeholders
• Proactively anticipates and facilitates future business opportunities with existing and prospective clients
• Independently conducts regularly scheduled touch bases with clients
• Maintains contract/project financial data
• Stay apprised of all repository and laboratory operations (fresh/frozen sample handling, data entry, shipping, etc.) if needed
• Reviews and approves all documentation associated with project(s) as required
• Following up on action items to ensure completion
• Project resource planning and reporting of project forecasts and actuals
• Track detailed technical deliverables and provide outlook on future deliverables
• Communicate with key business partners (internal and external) to ensure accurate and up to date information is maintained for program delivery
• Provide regular (weekly/biweekly) project communications with Clin Ops regarding key clinically meaningful data

Requirements:

• At least 3 years of clinical project management experience is strongly preferred
• Proven record of management of multiple trials and study teams
• Demonstrate working knowledge of internal SOP's, FDA/lCH guidelines to GCP's and regulatory compliance.
• Must have good organizational skills with the ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines
• Must have knowledge of and direct experience with Microsoft Office: Word, Excel, PowerPoint, OneNote, Outlook, and Adobe Acrobat
• Experience with controlled clinical terminology and clinical trial systems such as TMF/eTMF, CTMS, EDC, IVRS/IWRS, ePRO is highly preferred
• Excellent interpersonal, active listening, and influencing skills
• Strong attention to detail, critical thinking skills to identify and solve problems
• Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company and external partners
• Strong organizational skills in order to maintain a high level of productivity and setting priorities in order to complete assignments in a timely manner
• Exhibit high initiative, strong drive, and follow-through
• Effective project management and organizational skills
• Good computer skills
• Ability to effectively conduct oral presentations
• Demonstrated experience in identification and resolution of technical problems in a professional environment
• Ability to maintain a high degree of confidentiality with clinical teams
• Ability to attain, maintain and apply a working knowledge of applicable procedural documents
• Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others
• Excellent interpersonal, active listening, and influencing skills
• Excellent written and effective verbal communication skills. Read, write and speak fluent English; excellent verbal and written communication skills
• Team player. Able to establish and maintain professional and productive working relationships with team members
• Prior regulatory experience is a plus
• Ability to travel as needed

Education/Experience Required: The ideal candidate will offer:

• Bachelor's degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field 3+ years of clinical research experience in industry settings, as a CPM with additional responsibilities in line with Sr. CPM or Program Manager
• Previous industry experience as a CPM that provides the knowledge, skills, and abilities to perform the job or equivalent combination of education, training, & experience.

Please note the following:

• Applicants for this position must be legally authorized to work in the U.S.
• We are not currently sponsoring work visas.
• Relocation is not available for this position as it is a remote role.
• We are an Equal Employment Opportunity employer. Drug free workplace.
• We are following all state guidelines relative to safety precautions.

Job Title: Quality Systems Consultant
Classification: Full Time
Location: Remote
Travel (%): 50%

Company Summary:
MEDIcept is an international medical device, IVD, combination product and biotechnology compliance consulting firm. For over 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost- effective Regulatory, Quality, and Clinical services.

Please see www.medicept.com for more information.

Position Summary:
The Quality Systems Consultant is a hands-on role supporting the Quality Management Systems department. Must be a self-starter and a multi-tasker, as this position will work on multiple exciting client projects in tandem.

Essential Duties and Responsibilities:
• Successfully develop and manage Quality Management Systems to meet FDA QSR, ISO 13485, EU MDR, MDSAP, and other applicable regulatory requirements.
• Conduct / lead / assist clients with internal, supplier, ISO 13485, CE Mark, MDSAP audits and FDA inspections.
• Perform recidivist certification and due diligence audits.
• Compliance strategy development, including enforcement action responses and/or corrective action plans (483s, warning letters, etc.), recall strategies.
• Supplier Quality Management activities, including supplier audits and corrective action process (SCAR).
• Deliver customized client training and education programs.
• Corrective action strategy and development.
• Preparation for FDA inspections and registrar or Notified Body assessments.
• Identify client processes that may require improvement, correction, or additional contracted resources.
• Successfully plan, manage, execute, and close turnkey projects within budget, and on time.
• Develop strong relationship with clients, providing timely and accurate communications.
• Deliver customized client training and education programs on Quality Management Systems and other industry topics.
• Potentially serve as client adjunct quality staffing (Interim Quality Professional)

Skills and Qualifications:
• Bachelor’s degree in Engineering, Regulatory and Compliance Management, Quality Engineering, or in a closely related / equivalent field.
• Minimum five (5) years of experience monitoring and maintaining quality management systems to ensure compliance with government regulations within the medical device, life sciences industry.
• Auditing and in-depth knowledge and experience working with 21 CFR Parts 820, 803, 806 and ISO 13485, ISO 9001, EU MDR and related International Requirements.
• Lead Auditor or Auditor certification a plus.
• Proven hands-on experience with document management, training, CAPA, electronic system development/validation, management review, risk management, and quality improvement initiatives.
• Excellent communication (oral, written and verbal) and time management skills required.
• Must be detail-oriented, thorough, and organized.
• Excellent interpersonal skills with a customer service focus.
• Ability to manage multiple projects simultaneously.
• Must be self-motivated, able to work both independently and with a team.
• Software (ISO 62304) and Usability (ISO 62366) experience a plus.
• Project Management experience a plus.

Please note the following:
• Must be legally authorized to work in the U.S.
• We are not currently sponsoring work visas.
• Relocation is not available for this position as it is a remote role
• We are an Equal Employment Opportunity employer. Drug free workplace.
• We are following all state guidelines relative to safety precautions.

Investigator experience a must.

Classification: Full Time
Location: Remote (must be US based)
Travel: ~50%

Position Summary:

The Quality Systems Senior Consultant is a hands-on role supporting the Quality Management Systems department. Must be a self-starter and a multi-tasker, as this position will work on multiple exciting client projects in tandem.

Essential Duties and Responsibilities: (will be variable depending on the nature of the client projects to be undertaken)

• Successfully develop and manage Quality Management Systems to meet FDA QSR, ISO 13485, EU MDR, MDSAP, and other applicable regulatory requirements.
• Conduct / lead / assist clients with internal, supplier, ISO 13485, CE Mark, MDSAP audits and FDA inspections.
• Perform recidivist certification and due diligence audits.
• Compliance strategy development, including enforcement action responses and/or corrective action plans (483s, warning letters, etc.), recall strategies.
• Supplier Quality Management activities, including supplier audits and corrective action process.
• Deliver customized client training and education programs.
• Corrective action strategy and development.
• Preparation for FDA inspections and registrar or Notified Body assessments.
• Identify client processes that may require improvement, correction, or additional contracted resources.
• Successfully plan, manage, execute, and close turnkey projects within budget, and on time.
• Develop strong relationship with clients, providing timely and accurate communications.
• Deliver customized client training and education programs on Quality Management Systems and other industry topics.
• Potentially serves client adjunct quality staffing (Interim Quality Professional)

Skills Requirements:

• Bachelor’s degree in Engineering, Regulatory and Compliance Management, Quality Engineering, or in a closely related / equivalent field.
• Minimum ten (10) years of experience monitoring and maintaining quality management systems to ensure compliance with government regulations within the medical device, pharmaceutical, biotechnology, etc.
• Former FDA Investigator experience a must.
• Auditor and in-depth knowledge and experience working with 21 CFR Parts 4, 820, 210/211, 803, 806 and ISO 13485, 14971, EU MDR, EU IVDR and related International Requirements.
• Lead Auditor certification a plus.
• Excellent communication (oral, written and verbal) and time management skills required.
• Must be detail-oriented, thorough, and organized.
• Excellent interpersonal skills with a customer service focus.
• Ability to manage multiple projects simultaneously.
• Must be self-motivated, able to work both independently and with a team.
• Software (ISO 62304) and Usability (ISO 62366) experience a plus.
• Project Management experience a plus.

Please note the following:

• Applicants for this position must be legally authorized to work in the U.S.
• We are not currently sponsoring work visas.
• Relocation is not available for this position as it is a remote role.
• We are an Equal Employment Opportunity employer. Drug free workplace.
• We are following all state guidelines relative to safety precautions.

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Seniority Level: Mid-level
Industry: Medical Device / IVD / Biotech
Employment Type: Permanent
Location: Remote (must be US based)
Travel: Yes, candidate must have the desire and ability to travel

Company Summary:
MEDIcept is an international medical device, IVD, combination product and biotechnology compliance consulting firm. For over 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost- effective Regulatory, Quality, and Clinical services.

Please see www.medicept.com for more information.

Position Summary:
Technical, hands-on role to support our rapidly expanding Quality team. A self-starter and a multi-tasker, this individual will work on multiple exciting projects in tandem, with limited supervision. While software quality engineering experience in the medical device industry are must-haves, time management and communication are equally important.

Relocation to the Boston area is not required; successful candidate can work remotely from their home office and at client site as needed.

Essential Duties and Responsibilities:
• Work with clients to develop IEC 62304, ISO 13485, 21 CFR 820, 60601 compliant documentation (all product/software classifications)
• Design History File audits for compliance to IEC 62304, 60601, 21 CFR 820, ISO 13485.
• Serve as client Software Quality Engineering function including assistance with software development documents (including cybersecurity), risk management files, and 60601 deliverables.
• Must be able to assist clients with risk-based decisions using critical thinking
• Leading and mentoring Agile software teams:
o Development Lifecycle Planning
o Requirement Development
o Hazard Analysis
o Cybersecurity Threat Modeling
o Anomaly Analysis
o Verification documentation methods
o Automated testing
• Cybersecurity implementation development, including post-market Vulnerability Monitoring.
• Identify client processes that may require improvement, correction, or additional contracted resources.
• Successfully plan and manage multiple, parallel projects to successful completion, on time and within budget.
• Develop strong relationships with clients, providing timely and accurate communications.

Skills and Qualifications:
• Bachelor's degree in Engineering, Computer Science, or in a closely related / equivalent field.
• Minimum five years of experience in quality engineering including software quality environment within the Medical Device industry.
• Proven hands-on experience with implementation of IEC 62304, ISO 13485, and ISO 14971.
• Knowledge of AI/ML, Bluetooth, IoT, and mobile devices.
• Working knowledge of Part 11, IEC 60601, Human Factors, EU MDR, and medical device cybersecurity (e.g., UL 2900, AAMI TIR57 and TIR97, ISO 27001, IEC 62443, NIST SP 800-53, NIST 800-30, SOC Type 2).
• Hands-on ability to work autonomously to problem-solve.
• Excellent communication, time management, and analytical skills required.
• Experience with small / startup company desired.
• Electromechanical experience a plus, including knowledge of IEC 60601.
• Experience with regulatory submission content creation a plus.
• Must possess excellent verbal, time management, and written communications skills.
• Previous consulting and clientele relationship experience a plus.

Please note the following:
• Must be legally authorized to work in the U.S.
• We are not currently sponsoring work visas.
• Relocation is not available for this position as it is a remote role
• We are an Equal Employment Opportunity employer. Drug free workplace.
• We are following all state guidelines relative to safety precautions.