Manager, Clinical Operations Standards Systems

JOB SUMMARY

The Manager, Clinical Operations Standards & Systems (COSSM) will execute on the vision of the Clinical Operations Standards & Systems Lead (COSSL) and manage the implementation of operational standards and systems within the Clinical Operations department.

The incumbent supports Clinical Trial Management to ensure successful implementation of processes for inspection readiness. Assists Clinical Trial Management to execute inspection readiness activities throughout the lifecycle of a project and provides assistance to study teams prior to and during inspections.

May work with identified clinical systems and teams to provide the services or technology solutions necessary to further enable and advance clinical’s drug development capabilities.

Under the direction of the COSSL, authors and contributes to clinical department SOPs, Work Instructions (WIs) and other tools as appropriate. Further, the COSSM will contribute to the development of ensuring proper documentation of study-specific training.

The COSSM may manage direct report(s).

The incumbent works cross-functionally with internal departments, with input from relevant internal and external stakeholders on Clinical Operations related issues in relation to inspection readiness, systems, and training/SOPs.

The COSSM supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Job Description:

ESSENTIAL FUNCTIONS

Primary duties/responsibilities:

• Provides oversight and may lead some GCP inspection readiness activities, supporting project teams during inspections and audits.

• Provides assistance and guidance to Clinical Trial Management for the creation, development, and execution of Corrective and Preventative Actions (CAPAs).

• Authors and contributes to Clinical Operations Standard Operating Procedures (SOPs), guidance documents, and policies.

• Assists in creation, development and implementation of Clinical Operations process improvements, participating in individual projects and workstreams to create and improve upon departmental processes, and working with department leadership to create, establish, improve, and maintain operational processes.

• Provides guidance and assists study teams to ensure study-specific training is adequately handled and documented appropriately in LearningHub.

• Contributes to the vision and strategy for end-to-end clinical systems lifecycle management.

• Collaborates with internal and external partners for system and process implementation.

• May manage, coach and mentor direct reports.

• Performs other tasks and assignments as needed and specified by management.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

* Minimum level of education and years of relevant work experience.

• Bachelor’s degree in relevant discipline and a minimum of 6 years progressively responsible US and/or global experience in clinical operations in a pharmaceutical, biotechnology, Clinical Research Organization (CRO), university medical center or related environment.

* Special knowledge or skills needed and/or licenses or certificates required.

• Broad understanding of needs for standards, processes, and systems and implementation of practices to execute on these within Clinical Operations.

• Working knowledge of clinical trial design, conduct, data acquisition, and reporting.

• Current knowledge of ICH, GCP and other regulatory guidelines/directives as they relate to inspection readiness, process creation and implementation, and documentation requirements.

• Demonstrated leadership ability and experience managing, coaching and mentoring direct reports.

• Proficiency with Microsoft Office.

• Excellent verbal and written communication skills.

• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.

• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.

• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

*Special knowledge or skills and/or licenses or certificates preferred.

• Experience in writing SOPs, WIs, and guidance documents.

• Prior involvement in quality management, inspection readiness, developing processes, and/or training development within Clinical Operations.
• Experience with regulatory inspections and a demonstrated understanding of inspection readiness best practices.
• Previous clinical monitoring experience
• Experience leading and/or contributing to the selection and/or implementation of clinical technology, including Clinical Trial Management System (CTMS).

* Travel requirements

10-20%

* Office based position.

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.