![Advanced Clinical](https://media.trabajo.org/img/noimg.jpg)
Manager, Clinical Compliance
2 weeks ago
We are currently searching for a skilled professional to join a well-known client's team as a remote Manager, Clinical Compliance. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
This position provides GCP compliance support to Sponsor's therapeutic area and clinical study teams under the direction of the Sr. Manager or the Associate Director, Clinical Compliance. The key activity of the role is providing expertise and guidance regarding regulatory requirements, GCP guidelines, and Sponsor's Standard Operating Procedures (SOPs) for the conduct of clinical studies.
The position will utilize a risk-based strategy to prioritize compliance support for clinical activities, identify and escalate compliance issues, enable decision-making, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks. The Clinical Compliance Manager serves as an important conduit to the broader organization to ensure a culture of quality and compliance.
RESPONSIBILITIES
- Provide quality leadership and direction to Sponsor's R&D stakeholders on GCP-related activities/issues and act as GCP expert/consultant for R&D colleagues.
- Act as a Clinical Compliance member of clinical study teams for relevant Therapeutic Areas.
- Develop strong relationships with R&D personnel across functions and teams providing coaching and compliance guidance as needed.
- Collaborate with stakeholders in conducting ongoing risk assessment of clinical trial activity to identify priority studies, compliance metrics for tracking, high-risk vendors, and key compliance activities (i.e., protocol review, vendor evaluations, inspection readiness).
- Identify and escalate significant quality and compliance issues to the Head of Clinical Quality & Compliance and relevant leadership, including the assessment of serious breaches.
- Participate as a member of Contract Research Organization (CRO)/Vendor governance teams for assigned Therapeutic Areas/Studies.
- Establish a relationship with CRO Quality Team members for the ongoing review of quality and compliance issues.
- Participate in vendor evaluations as a Subject Matter Expert (SME) as needed.
- Support clinical teams/functions in drafting responses and CAPAs to internal and external audit findings.
- Provide support and guidance for Sponsor's Quality Management System activities including self-reporting deviations, root cause analysis, and CAPA plan development and evaluation.
- Identify and anticipate trends in quality issues and collaborate with functional management to ensure risk-managed solutions are implemented in a timely fashion.
- Maintain a high level of expertise in international GCP regulations and internal Policies and Procedures that may impact drug development.
- Provide support and guidance during and following internal audits and external regulatory inspections (as required).
- Provide expertise and consultative guidance on business initiatives involving systems, processes, procedures, regulations, and tools intended for use in clinical trial conduct and/or regulated drug development activities.
- Lead / manage inspection readiness activities and ensure project teams are trained and prepared for regulatory inspections.
- Minimum of 5 years in the academic, pharmaceutical or biotechnology industry experience, with 3+ years in a clinical compliance, quality assurance, or regulatory compliance role.
- Bachelor's Degree is required; degree in life science or related discipline preferred.
- Thorough knowledge and understanding of drug development and the clinical trial process.
- In-depth knowledge of current regulatory and ICH GCP requirements and experience with international regulations, guidelines and standards is required. Working knowledge of CAPA management, risk management, regulatory inspections and GLP requirements is a plus.
- Excellent written and verbal communications skills with the ability to influence others and gain commitment.
- Ability to work in an entrepreneurial and fast-paced culture.
- Must be disciplined, detail-oriented, and able to multitask and work efficiently and independently.
- Ability to collaborate and partner with various internal business partners.
- Ability to work in a team environment.
- Highly developed problem-solving skills and the ability to resolve difficult conflicts.
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You're an efficient time manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you're eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Detailed understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune's Top Workplaces, Chicago's Best and Brightest Companies, and Best of Staffing Talent & Client, visit
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
-
QA Compliance lead
2 weeks ago
Deerfield Beach, Florida, United States Baxter Full timeVantive: A New Company Built On Our LegacyBaxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care...
-
Analyst, Compliance
2 weeks ago
Deerfield Beach, Florida, United States Nutrien Full timeAt Nutrien, our purpose is Feeding the Future and we do so with safety, inclusion, integrity and results as our core values. Nothing is more important than sending our people home safe, every day.Nutrien is a leading provider of agricultural products, services, and solutions. With nearly 25,000 employees world-wide, we are the largest producer of potash (by...
-
Analyst, Compliance
3 weeks ago
Deerfield Beach, Florida, United States Nutrien Full timeAt Nutrien, our purpose is Feeding the Future and we do so with safety, inclusion, integrity and results as our core values. Nothing is more important than sending our people home safe, every day.Nutrien is a leading provider of agricultural products, services, and solutions. With nearly 25,000 employees world-wide, we are the largest producer of potash (by...
-
Clinical Trial Educator
3 weeks ago
Deerfield Beach, Florida, United States Randstad USA Full timejob summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A...
-
Clinical Trial Educator
2 weeks ago
Deerfield Beach, Florida, United States Randstad USA Full timejob summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A...
-
Clinical Trial Educator
3 weeks ago
Deerfield Beach, Florida, United States Randstad USA Full timejob summary: As the largest staffing and recruitment agency in the world, we can commit to finding you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. A...
-
UCAN COE Manager
1 week ago
Deerfield Beach, Florida, United States Baxter Full timeUCAN COE ManagerThis is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxter's products and therapies are...
-
Maintenance Manager
3 weeks ago
Deerfield Beach, Florida, United States Michael Page Full timeAbout Our Client My client is an industry leader in industrial manufacturing, dedicated to delivering high-quality products. With a commitment to innovation and excellence, all products are manufactured to the highest quality standards. Job Description The Maintenance Manager will report directly into the Operations Manager and be responsible for: Oversee...
-
Maintenance Manager
2 weeks ago
Deerfield Beach, Florida, United States Michael Page Full timeAbout Our Client My client is an industry leader in industrial manufacturing, dedicated to delivering high-quality products. With a commitment to innovation and excellence, all products are manufactured to the highest quality standards. Job Description The Maintenance Manager will report directly into the Operations Manager and be responsible for: Oversee...
-
Technical Accounting Manager
1 week ago
Deerfield Beach, Florida, United States Baxter Full timeThis is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in...
-
Deerfield Beach, Florida, United States Baxter International Inc. Full timeVantive: A New Company Built On Our LegacyBaxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care...
-
Deerfield Beach, Florida, United States Baxter International Inc. Full timeVantive: A New Company Built On Our LegacyBaxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care...
-
Maintenance Manager
5 days ago
Deerfield Beach, Florida, United States Michael Page Full timeAbout Our Client My client is an industrial manufacturer of precision components used in several industries such as aerospace and defense. They have been in business for over 30 years and have been rapidly growing, giving their employees opportunity for upward mobility. Job Description The responsibilities of the Maintenance Manager include, but are not...
-
Consolidations - Accounting Manager
2 months ago
Deerfield Beach, Florida, United States Baxter International Inc. Full timeThis is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxter's products and therapies are found in almost...
-
Management Trainee
3 weeks ago
Deerfield Beach, Florida, United States Cintas Full timeRequisition Number: 156778Job DescriptionCintas is offering a Management Trainee program to college graduates designed to prepare you for your professional life. We have the same goals. You want an exceptional job, and we want a dedicated employee-partner to join our team and lead our company. Cintas is currently seeking a Management Trainee to participate...
-
Quality Assurance Manager
2 weeks ago
Deerfield Beach, Florida, United States Pelican Full timeSUMMARY Be a Champion for Legendary Durability. Pelican Products is renowned for its virtually indestructible products. As our Quality Manager, you'll play a critical role in upholding this legacy by ensuring every product leaving our facility meets our rigorous quality standards. You'll be a champion for continuous improvement, leading a team and...
-
Quality Assurance Manager
3 weeks ago
Deerfield Beach, Florida, United States Pelican Full timeSUMMARY Be a Champion for Legendary Durability. Pelican Products is renowned for its virtually indestructible products. As our Quality Manager, you'll play a critical role in upholding this legacy by ensuring every product leaving our facility meets our rigorous quality standards. You'll be a champion for continuous improvement, leading a team and...
-
Assistant Front Office Manager
2 weeks ago
Deerfield Beach, Florida, United States Deerfield 21 Corp Full timeDescription:Join our dynamic hospitality team as an Assistant Front Office Manager and be the cornerstone of our guests' experience In this pivotal role, you'll assist in leading our front desk operations, ensuring exceptional service standards, and creating memorable guest interactions. If you're passionate about delivering outstanding customer service and...
-
Assistant Front Office Manager
2 weeks ago
Deerfield Beach, Florida, United States Deerfield 21 Corp Full timeDescription:Join our dynamic hospitality team as an Assistant Front Office Manager and be the cornerstone of our guests' experience In this pivotal role, you'll assist in leading our front desk operations, ensuring exceptional service standards, and creating memorable guest interactions. If you're passionate about delivering outstanding customer service and...
-
Assistant Front Office Manager
1 month ago
Deerfield Beach, Florida, United States Deerfield 21 Corp Full timeDescription:Join our dynamic hospitality team as an Assistant Front Office Manager and be the cornerstone of our guests' experience In this pivotal role, you'll assist in leading our front desk operations, ensuring exceptional service standards, and creating memorable guest interactions. If you're passionate about delivering outstanding customer service and...