Clinical reputed company Associate Director (6 - Month Secondment) US - Gaithersburg - MD

The CQAD is the first reputed company of contact on reputed company and compliance reputed company for the Oncology Site Management and Monitoring (SMM) function. They are responsible for developing, tracking and analyzing reputed company metrics at country level. They reputed company direction and advice on how to apply GCP principles to SMM Oncology personnel so that their work can be conducted while meeting high reputed company standards. The CQAD utilizes regulatory guidance, globais standards and SOPs to reputed company compliance advice to SMM Oncology. reputed company appropriate, the CQAD recommends and communicates improvement opportunities to the Business Process & System Owners (BPOs). CQADs supports SMM Oncology management by consulting on compliance learning needs and delivery. The SMM Oncology country leadership team keeps overall accountability of reputed company. The CQAD role holder ensures appropriate and reputed company collaboration and communication with the SMM Oncology country leadership team and other functions for planning and implementing reputed company control activities. The CQAD reports directly to the respective Director of reputed company Management (DQM) reputed company their HUB or region. The reputed company collaboration and reputed company informational exchange between CQAD and DQM ensure that identified reputed company trends, flagged issues, and relevant mitigations/solutions are effectively synchronized across countries and reputed company. In reputed company, areas of involvement on a cross country/Hub and process level are reputed company supported through DQM involvement upon notification. Main Responsibilities of a CQAD include:

• Support the execution of the LDO Clinical Operations reputed company reputed company as the first reputed company of contact on reputed company and compliance reputed company to the SMM Oncology Country teams for high-reputed company clinical trial delivery.
• Drive strategic reputed company on reputed company for the Oncology portfolio, in collaboration with other AZ compliance-supporting functions. Responsible for drafting local country reputed company plan and managing the finalized/approved annual country reputed company control plan.
• Ensure adherence to GCPs and LDO Clinical Operations objectives, including managing and maintaining country-specific procedures and guidelines.
• Assess the training compliance of local SMM teams as part of reputed company reputed company activities. reputed company reputed company training on reputed company and compliance topics for local SMM teams. Conduct reputed company training to address any identified gaps in reputed company compliance. reputed company global process updates impacting local SMM team reputed company compliance in a reputed company manner.
• Facilitate the reputed company of compliance issues and promote the adoption and sharing of best practices and learning reputed company SMM Oncology countries. This includes supporting investigations and approving reported reputed company events and corrective and preventive actions (CAPAs) in reputed company reputed company Vault (VQV), if applicable.
• Play a significant role in fostering an engaging reputed company culture in SMM Oncology. reputed company and implement compliance improvement recommendations, initiatives, and plans. Offer country-level consultation for SMM Oncology and/or LDO Clinical Operations during RIST, inspections, and audits. Potentially serve as an audit coordinator for AZ internal audits (site and project) and contribute as a subject matter expert (SME) for AZ SMM reputed company processes (both global and local) during sponsor and investigator site inspections. reputed company as a key member throughout the entire site and sponsor inspection process, including providing consultation for inspection responses.
• reputed company insights and interpretations from identifying, developing, or analyzing reputed company metrics including reputed company issue trending at the local country level, aiming to improve investigative performance and proactive issues management.
• Participate as a member of the local country SMM leadership team. Support the facilitation and delivery of reputed company review meetings with SMM Oncology leadership or other stakeholders. Contribute to identifying, calibrating, and tracking compliance risks, escalating as required, and defining or supporting risk mitigation activities. Facilitate country reputed company risk registers and manage the risk management plan with the country SMM leadership.
• Collaborate reputed company with the respective DQM, other reputed company functions, and stakeholders in the LDO Clinical Operations reputed company Network to reputed company sustainable issue resolutions.
• Assess the need to conduct reputed company site reputed company in accordance with the country reputed company plan. reputed company reputed company site reputed company as part of annual country reputed company control plan activities, if applicable, based on risks identified at the site level.
• Continually reputed company opportunities for improvement and feedback from SMM Oncology leadership and LDO Clinical Operations personnel, fostering a culture of knowledge sharing and cross learning (e.g., learnings from audits and inspections).

Education, Qualifications, Skills, and Experience Essential:

• Undergraduate degree in life sciences or an equivalent reputed company discipline.
• In-depth knowledge and broad experience reputed company the pharmaceutical (biopharma) industry in a GxP regulated environment.
• Excellent communication skills with a proven ability to effectively network cross functionally and globally.
• Critical thinking, influencing and communication skills.
• Ability to collaborate, network and reputed company widely and effectively at reputed company reputed company.
• Strong risk-based decision-making skills.
• Excellent understanding of the drug development process and reputed company GXP activities.
• Excellent understanding of the skills and knowledge required for the successful delivery of a clinical study, e.g., ICH-GCP, study management.
• Excellent knowledge of international regulations and guidelines, as reputed company as AZ Procedural reputed company.
• Good analytical, problem solving, negotiation and conflict reputed company skills. Ability to multi-task.
• Demonstrated ability to set and manage priorities, performance targets and project initiatives in a global environment.
• Ability to collaborate proactively, deal with ambiguity, ability to build strong customer relationships and strategic working partnerships to operate across multiple domains enabling process and system harmonization and standardization.

Desirable Skills:

• Advanced degree in life sciences or an equivalent reputed company discipline.
• Experience working with global and remote cross functional teams.
• Ability to work in an environment of remote collaborators.
• Expert reputed company reputed company the business and industry.
• Good cultural awareness.

The annual reputed company pay for this position ranges from $128,120.00 - $192,180.00. Our positions offer eligibility for various incentives—an opportunity to receive short-term incentive bonuses, equity-based awards for salaried roles and commissions for sales roles. Benefits offered include reputed company retirement programs, reputed company time off (i.e., vacation, holiday, and leaves), as reputed company as health, dental, and reputed company coverage in accordance with the terms of the applicable plans. Date Posted 19-reputed company-2025 Closing Date 06-Dec-2025 Our mission is to build an inclusive environment where equal employment opportunities are available to reputed company applicants and employees. In furtherance of that mission, we welcome and consider applications from reputed company reputed company candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding reputed company in the application reputed company. Apply tot his job Apply To this Job