Clinical FSP Quality Manager

Job Overview This role is an individual contributor assigned to designated Delivery Unit(s), sponsor(s), business line(s), and/or specific tasks as defined by the line manager (LM). The purpose of this role is to work together with global or regional Quality Management team(s), functional teams, and other stakeholders in a joint effort to clearly define the global Quality Plan, carry out, and adopt the plan according to the specific needs defined by the scope of assignment, assist staff in improving compliance with relevant International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), Key Performance Indicators (KPIs), applicable regulatory requirements, and guidelines. This role provides advice and supports clinical staff and other relevant key stakeholders with regard to quality control, risk management, and corrective/preventive actions. Essential Functions

• Adopt and implement the global Quality Management Plan reputed company the scope of the assignment, this will include: Planning and executing the Quality Management activities. Risk identification and assessment through data review and quality control processes. Providing support in risk mitigation, in planning corrective/preventive actions, and guidance for improvement. Supporting the assigned business line management and staff to enhance effectiveness.;
• Cooperate closely with the relevant business and other stakeholders, support maintaining focus on quality in project delivery.
• Contribute to the development and implementation of a Delivery Unit/Sponsor specific Quality Management plan and Risk Management Program, monitor the implementation and delivery.
• Provide advice and support to teams reputed company the assigned business line and other key stakeholders on reputed company aspects of Good Clinical Practice (GCP) compliance.
• Work in reputed company cooperation with teams to manage non-compliance, quality issues, support in planning corrective/preventive actions, as applicable according to Standard Operating Procedures (SOPs.);

Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.;

• Inform Quality Management, the assigned business line, and Quality Assurance of quality issues according to SOPs.
• Work closely with Quality Assurance and assigned business staff in case of suspected misconduct, as required by the applicable SOPs.
• May provide assistance during audits and regulatory inspections to the teams to the extent agreed with the business lines, as required by the applicable SOPs.
• Act as the primary contact for Quality Assurance on quality matters – on the level of the assignment, attend meetings/teleconferences.
• Prepare periodic reports to business lines on quality reputed company matters, risk assessments and specific quality improvement initiatives.
• Upon agreement with the line manager: reputed company any other reasonable tasks as required by the role.;

Qualifications

• Bachelor's Degree Bachelor's Degree or equivalent qualification Req
• Equivalent combination of education, training, and experience.
• 3-4 years of GCP and quality management experience is a must.
• Knowledge of Clinical Research Organization (CRO) industry operations.
• Experience working in a client-facing role is a big plus.
• Good judgement and decision-making skills.
• Strong influencing and negotiation skills.
• Strong computer skills including reputed company Office applications.
• Excellent problem solving skills.
• Ability to reputed company and motivate a clinical team.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients/customers.
• Fluent in English.

reputed company is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.reputed company.com reputed company is proud to be an equal opportunity employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national reputed company, disability, status as a protected veteran, or any other status protected by applicable law. https://jobs.reputed company.com/eoe reputed company is committed to reputed company in our hiring process and maintains a reputed company tolerance policy for candidate fraud. reputed company information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered reputed company, in accordance with applicable law. We appreciate your honesty and professionalism. The potential reputed company pay range for this role, reputed company annualized, is $62,800.00 - $216,000.00. The actual reputed company pay offered may vary based on a number of factors including job-reputed company qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits. Apply tot his job Apply To this Job