Job Description

This is a 12-month contract with possibility of extension!

Job Title: Clinical Governance Operations Manager

Location: Remote, preference to area around Billerica, MA

Company: EMD Serono

Job Type: Contract

Overview:

We are seeking a skilled and dynamic Clinical Governance Operations Manager to facilitate and moderate our cross-functional protocol review committee for clinical studies. The role will play a crucial role in ensuring that our clinical study protocols and operational plans (timeline, budget) are reviewed effectively and align with regulatory standards, best practices, as well as corporate objectives. The role will also be involved in management of our medical affairs study governance as well as program and portfolio governance processes.

This position requires strong communication skills, a strong understanding of clinical operations processes and the ability to foster collaborative discussions among diverse stakeholders. The ideal candidate will possess strong leadership skills, a comprehensive understanding of clinical governance at study and portfolio level, and the ability to drive collaboration across various functions.

Key Responsibilities:

• Facilitation of Meetings: Organize and lead meetings of the clinical study protocol review committee (iPRC), ensuring that discussions are focused, productive, and adhere to the agenda.
• Protocol Review: Assist in the review of clinical study protocols, providing guidance on best practices, regulatory requirements, and ethical considerations, ensuring compliance with Good Clinical Practice (GCP) and other relevant regulations
• Documentation: Ensure accurate and comprehensive documentation of meeting minutes, decisions made, and action items assigned to committee members.
• Medical Governance: Facilitate Medical Study governance processes, ensuring that all medical studies are conducted in compliance with Good Clinical Practice (GCP) and other relevant regulations.
• Program and Portfolio Governance: Manage the governance processes for clinical development programs and portfolios, ensuring alignment with organizational strategy and objectives.
• Stakeholder Engagement: Collaborate with various stakeholders, including clinical researchers, regulatory affairs, and quality assurance teams, to gather input and address concerns during protocol reviews.
• Conflict Resolution: Manage and resolve any conflicts or disagreements that may arise during discussions, promoting a respectful and inclusive environment.
• Training and Support: Provide training and support to committee members on the review process, protocol requirements, and relevant regulatory guidelines.
• Continuous Improvement: Identify opportunities for process improvements within the assigned governance processes and implement changes to enhance efficiency and effectiveness.

Qualifications:

• Advanced degree in Life Sciences, Medicine, Medical Writing, or a related field; doctorate preferred.
• Minimum of 5 years of experience in clinical development, clinical operations (such as clinical project manager, clinical trial coordinator, medical monitor, clinical data coordinator, etc.), medical writing or a related field, with a focus on protocol development & review as well as clinical study planning & operationalization.
• Strong understanding of Good Clinical Practice (GCP) guidelines, regulatory requirements, and ethical considerations in clinical research.
• Excellent verbal and written communication skills, with the ability to articulate complex concepts clearly and effectively.
• Proven ability to facilitate discussions, manage conflicts, and build consensus among diverse stakeholders.
• Strong organizational skills and attention to detail, with the ability to manage multiple priorities and meet deadlines.
• Proficiency in Microsoft Office Suite and experience with electronic document management systems or workflow tools.
• Experience in a pharmaceutical or biotechnology company, particularly in a governance or oversight role.
• Familiarity with clinical trial management systems (CTMS) and experience in data visualization is a plus.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

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