Director, Headquarters Clinical Quality Management - Oncology Job - United States
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
Under the guidance of Headquarters Clinical Quality Management Lead the HQ CQM Director will oversee clinical quality management within the Oncology Therapeutic Area supporting Clinical Trial Teams (for in or outsourced trials) to proactively embed quality into Merck sponsored trials and address any quality issues as needed.
The incumbent will be responsible for the development of Quality Plans to implement Quality by Design within Clinical Development Programs, using a risk based approach and collaborating in implementing, and executing of the Quality Control activities at Headquarters (e.g. through central monitoring) as well as in the countries (e.g. through targeted Quality Control Visits at selected sites).
The incumbent will manage a team of HQ CQMs and will work with employees cross functionally and divisionally to manage and/or co-lead key initiatives charged with executing the continuous improvement initiatives in Clinical Research.
HQ CQM Director: CORE Accountabilities and Responsibilities:
- Leads a team of HQ CQMs to ensure creation of Quality Plans and oversees quality metric reviews for Oncology Clinical Development Programs and trials.
- Quality Management subject matter expert who provides real-time, proactive advice and guidance on procedures and issues relating to Quality, Compliance and Global Processes related to clinical development program management, clinical trial activities and vendor oversight.
- Collaborates with the Oncology HQ CQM Lead to facilitate appropriate quality issue escalation and resolution in accordance with all applicable change management processes.
- Leads review and resolution of Significant Quality Issues.
Audit and Inspection Support:
- Supports development of Story Boards for Oncology Clinical Development Programs and pivotal clinical trials to implement a risk based mitigation approach in view of inspection readiness.
- Supports preparation activities with the Global Inspections Management group for trial-related sponsor and/or site-related health authority inspections.
- Supports the development of responses to audits and inspections and ensures appropriate CAPA implementation.
- Ensures that all actions and commitments are implemented in a timely manner.
- Escalates issues to HQ CQM Lead from discussions/meetings with other functional areas.
Quality Signal Detection:
- Collaborates with MRL QA to gain an in depth knowledge of current audit and inspection trends across and within programs.
- Develops, implements and analyzes oncology-specific holistic quality plans (risk based approach) to detect quality signals before they are identified as audit observations and/or inspection findings.
- Trends known quality issues, coordinates global and regional investigations.
- Develops and manages targeted quality control visits, including the analysis and development of appropriate action plans in agreement with defined thresholds.
Quality Signal Analysis:
- Provides processes, systems and knowledge needed to proactively disseminate known and potential quality issues from local/regional to global perspective.
- Supports management and Therapeutic Area staff by providing an ongoing consolidation and current overview of known issues.
Quality Issue Prevention:
- Deploys and maintains global Quality Information management tools (e.g. Story Boards) to track and trend issues as well as manage them through their implementation life-cycle.
- Implements a Quality by Design approach from initial Protocol through Clinical Study Report.
- Provides input and approves trial specific monitoring plans.
- Supports qualification and quality management of global vendors.
- A Bachelor's Degree with 14 years of relevant quality management and/or clinical trials experience OR a Master’s Degree with 10 years of quality management and/or clinical trials experience is required.
- People management experience.
- Knowledge of Transcelerate and ICH E6, Rev. 2
- Experience and Knowledge in Quality Management in the Clinical Trial setting, GCP Auditing and GCP Inspections with a demonstrated record of accomplishments.
- Knowledge and understanding of quality management and control tools is required.
- Experience in Oncology Therapeutic Area, specifically related to design of trials and therapeutic area specific clinical assessments and medical practice (Clinical trial management and/or direct clinical trial field monitoring experience (Lead CRA Role).
- Experience in developing and delivering effective Corrective and Preventive Actions (CAPA) management solutions.
- Superior oral and written communication skills in a global environment.
- Excellent project management and organizational skills.
- Excellent teamwork and leadership skills, including conflict resolution expertise and discretion.
- Ability to leading cross-functional teams of business professionals.
- Ability to analyze, interpret, and solve complex problems.
- Ability to think strategically and objectively and with creativity and innovation.
- Ability to proficiently interact with all levels of management and exert influence to achieve results.
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Job: Clinical Research Generic
Job Title:Dir, Clinical Research
Primary Location: NA-US-PA-Upper Gwynedd
Other Locations: NA-US-NJ-Rahway
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Oncology, Clinic, Medical, Manager, Program Manager, Healthcare, Management