Clinical Quality Operations Manager

If you join us, you will work with some of the worlds leading pharmaceutical, biotechnology, and medical device companies in a vital stage of clinical development: establishing the safety, tolerability and pharmacokinetics of a new drug.

WHAT YOU WILL DO

You will utilize your skills, knowledge, and clinical judgement to provide a high standard of care for participants in clinical trials and respond to emergency situations based upon clinical research standards.

Key responsibilities:

• It is critical that, for all sponsor-sponsored clinical trials, patient safety, high quality data and compliance with company requirements and regulations are delivered and sustained. The CCQM position has a significant impact in achieving those objectives.

• Under the guidance of the Regional Director, Clinical Quality Management (RCQM), the CCQM oversees all CQM activities in the respective country/cluster.

• The role requires the ability to properly implement local/global processes/procedures, to identify opportunities for process improvement and to support continuous improvement initiatives. In addition, the CCQMs support audits, inspections as well as Quality Control and local training activities.

• Local expert for ICH-GCP and local regulations (incl. impact assessment of new/updated local regulations on local processes).

• In close collaboration with local country operations management, manages the local network of owners / Subject Matter Experts (SMEs) for global/local processes to ensure a proper implementation of global/local processes and the regular update of local Standard Operating Procedures (SOPs) / Work Instructions (WIs).

• Local expert for any quality-related local processes.

• Identifies process gaps / opportunities for process improvement and properly escalates to RCQM and/or Global Process Owners (if necessary).

• Leads continuous quality improvements activities at the country level as agreed with Country/Cluster CRD and RCQM and supports or co-leads continuous improvements activities at the global/regional level

• In mutual agreement with local country operations management and the RCQM, performs QC activities (incl. QCVs) and conducts ad hoc site visits upon request.

• Primary local point of contact for sponsor Quality Assurance and Regulatory Agencies.

• Manages and supports activities during the preparation / ongoing / follow-up phase of an audit or inspection.

• Communicates/escalates quality/compliance issues (incl. any potential trends) to local country operations management and RCQM.

• Supports global/regional key initiatives/projects upon request of the RCQM.

YOU NEED TO BRING...

• University/college degree (life science preferred) or certification in a related allied health profession (i.e., nursing, medical or laboratory technology) from an appropriately accredited institution.

Experience:

• A minimum of 6-8 years of relevant experience in clinical research including direct field monitoring experience or management/oversight of such individuals, with a demonstrated record of accomplishments. Experience in Country Operations preferred

• Deep knowledge and understanding of Clinical Trial processes, GCP and other clinical research related regulations.

• Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.

• Demonstrated experience in leading cross-functional teams.

• Experience in Clinical Quality Management including Quality Control Activities, Process Management & Improvement.

• Experience in managing audits and inspections.

• Strong clinical quality experience, specifically rooted in clinical trial operations.

• Candidates with manufacturingbased quality backgrounds are less aligned unless they also have significant clinical exposure.

• GCP experience is mandatory; GMP/GLP backgrounds are not sufficient.

• Must have participated in regulatory audits and regulatory inspections (not just quality audits).

• Experience leading interactions with key stakeholders, including CTTs, and providing quality guidance.

What do you get?

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:

• Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)

• 401(K)

• Paid time off (PTO)

• Employee recognition awards

• Multiple ERG's (employee resource groups)

• Salary range of 120-132,000k USD

Physical Demands/Work Environment:

• Work Environment:

• Work is performed in an office environment with exposure to electrical office equipment.

• Frequent travel to clients/ site locations with occasional travel both domestic and international.

• Travel requirements: 20%

  Physical Requirements:

• Ability to sit for extended periods and operate a vehicle safely.

• Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.

• Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.

• Ability to access and use a variety of computer software developed both in-house and off-the-shelf.

• Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.

• Regular and consistent attendance.

• Varied hours may be required.

Learn more about our EEO & Accommodations request here.