Senior Manager Clinical Compliance and Inspection Readiness 1/16/2020
JOB DESCRIPTIONAPPLY OVERVIEW
We are currently searching for a skilled professional to join a well-known client's team as a Senior Manager Clinical Compliance and Inspection Readiness in Cambridge, Massachusetts. The Senior Manager Clinical Compliance and Inspection Readiness role will assist in shaping the Compliance and Operational Excellence Team. In addition, this role will collaborate cross-functionally to drive best practices, create tools, implement lessons learned, and improve future capabilities, making this an amazing career opportunity.
* Ensure trial compliance is in accordance with regulations, SOPs, and processes
* Define, implement, and manage solutions to inspection readiness issues
* Manage oversight of inspection readiness activities
* Act as the subject matter expert for relevant functional areas on Inspection Support/Inquiries to help drive inspection readiness
* Develop/improve GCP Inspection and Compliance Management strategy, processes, tools, and templates
* Identify issues and resolutions associated with inspection readiness activities
* Measure and manage functional area documentation and deliverables relating to inspection readiness
* Minimum of 8 years of clinical research experience gained with a CRO, biotech, or pharmaceutical company required
* Experience in supporting Regulatory Authority (FDA, EMA, MHRA) GCP inspections preferred
* Knowledge of global clinical trial execution, drug development process, and operations required, experience preferred
* Working knowledge of clinical trial management activities in an outsourced CRO model
* Experience with supporting audits, development of CAPAs, and monitoring their implementation
* Excellent communication skills, verbal, written, and presenting
* Good knowledge of Clinical Development Activities and ICH-GCP guidelines
* Minimum of Bachelor's Degree required
To be a best-fit your strengths must include
* Strong Communicator. You'll have 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 with a team and also work effectively independently without a lot of support or structure.
* Problem-Solver. As an action-oriented self-starter, you apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions.
* Personable. You establish and nurture highly effective relationships that support and advance project goals and objectives.
* Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
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, visit http://www.advancedclinical.com.
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 thoughtfully reviewing and responding to each application. We ask for your patience as careful review takes time.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, disability, 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 to discuss the appropriate alternatives available.