Job Details

GCP Compliance Oversight Manager

Join Thermo Fisher Scientific Inc. as an outstanding GCP Compliance Oversight Manager and play a crucial role in ensuring the flawless execution of clinical trials. This is an outstanding opportunity to work in a world-class healthcare environment where your expertise will contribute to groundbreaking scientific advancements.

Job Responsibilities

• Leads small to mid-sized process improvement initiatives, implementing sustainability and effectiveness strategies.
• Proactively conducts risk assessments and supports mitigation planning for improvement projects.
• Assists in updating and maintaining procedural documents.
• Provides recommendations for increased efficiency and compliance through review of process documents and process maps.
• Supports cross-functional teams in implementing process changes and ensuring adherence to best practices.
• Contributes to training programs and process governance discussions.
• Provides mentorship and guidance to developing team members.
• Represents the department as a prime contact on projects. Interacts with internal and external personnel on significant matters often requiring coordination between functional areas.
• Networks with senior internal and external personnel in own area of expertise.
• Performs proactive as well as routine evaluation of clinical trial processes to determine adherence to process and procedural documentation through documentation review and active engagement with study team functional representatives.
• Helps develop and maintain KPIs, metrics and dashboards to track process quality and compliance.
• Provides near real-time feedback on study process and documentation quality as well as team performance and understanding on evaluated processes.
• Represent GCP Compliance in meetings as needed.
• Performs other duties as assigned.

Knowledge, Skills and Abilities

• Thorough understanding of procedural documents.
• Strong understanding of process improvement fundamentals.
• Solid investigative and analytical skills.
• Strong negotiation skills.
• Thorough understanding of clinical management technology and systems, and strong computer skills.
• Effective judgment, decision making, escalation, and risk management skills.
• Effective oral and written communication skills including the ability to communicate in English, both orally and in writing.
• Strong interpersonal skills and problem solving ability.
• Capable of directing and promoting teamwork in a multi-disciplinary and/or multi-cultural team setting.
• Strong attention to detail.
• Thorough understanding of regulatory guidelines and directives.
• Strong creative and critical thinking skills.

Qualifications

• Education and Experience: Bachelor's degree or equivalent and relevant formal academic / vocational qualification.
• Minimum of 4+ years clinical research experience in pharmaceutical or biotechnology field.
• Bachelor's degree preferred.
• MUST HAVE experience working within a GCP Environment.
• Solid knowledge of and experience in GCP compliance, regulatory inspection readiness.
• Solid knowledge of drug development, GCP compliance processes.
• Experience in problem solving, negotiations and collaborative team building with non-direct reports and other stakeholders is required.
• Solid knowledge of regulatory requirements governing clinical trial, industry best practices and related standard and documentation requirements.
• Must be able to efficiently utilize computer software programs such as Microsoft Office for general use, project management and presentations.
• Effectively resolve conflict in a constructive manner.
• Clinical research experience in all phases of clinical study life cycle, including start-up, interim and close-out, is preferred.
• Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job.

Physical Requirements / Work Environment

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements, including infectious agents, typically found in healthcare or laboratory environments.
• Able to perform optimally while balancing and prioritizing multiple projects or activities.

Benefits

• We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.
• Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects.
• We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
• Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.