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Manager, Clinical Safety & Compliance

Kelly Services


Location:
Hayward, CA 94540
Date:
08/29/2018
2018-08-292018-10-19
Categories:
  • Government
  • Information Systems
  • Healthcare
  • Regulatory Affairs
  • Monitoring
  • Data Management
Kelly Services
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Job Details

Kelly Scientific Resources is a specialty service of Kelly Services. As the world's largest provider of HR solutions to the scientific community, Kelly Scientific Resources is focused exclusively on placing skilled scientific professionals in contract, contract-to-hire, and full-time science jobs across a full spectrum of related industries and disciplines. Our scientists contribute to the research and development of therapeutics that change the lives of those affected with disease. We have an exciting direct hire opportunity in the Hayward, CA for Manager Clinical Safety and Compliance.





**Manager, Clinical Safety & Compliance**



Purpose and Scope



The Manager of Clinical Safety & Compliance is responsible for general safety and compliance oversight of clinical studies. In this position, the Manager is responsible for overseeing safety program, including management of the Clinical Events Committee (CEC) and, if required, Data Monitoring Committees (DMC). When US clinical trials are part of a global development program, the Manager will assure that the trials meet global standards so that the data can be used in all major markets. The Manager of Clinical Safety & Compliance is involved in the scientific conduct of clinical trials to guarantee release of high quality data in close collaboration with the VP of Regulatory/Clinical Affairs.





The Manager of Clinical Safety and Compliance is also responsible for clinical study compliance. This includes the periodic audits of the clinical procedures and implementation, clinical studies, and periodic quality assurance audits of investigational sites.



Responsibilities




+ Manage the safety program of all of clinical trials. This includes the assessment of all AEs, SAEs for reportability and for those that require adjudication the management of safety program also includes case review of each patients file and working with consulting medical monitor or chief medical officer to interpret data.

+ Conduct safety data analysis and trending, and identifying appropriate corrective action of events or event rate that may be alarming, including immediate communication of alarming events to the VP of RA/CA and/or the impacted investigator.

+ Periodic reporting of safety data to clinical affairs and to management;

+ Manage the Clinical Events Committee (CEC) and/or Data Monitoring Committee (DMC), if applicable, by working to select appropriate membership, creating charters, and case report forms for safety oversight. This includes preparing or supervising the preparation of safety dossier packages, forms, and procedures and coordinating meetings and final safety events adjudication;

+ Manage training and initiation of medical monitors, CEC, DMC or others participating in clinical trials with regards to safety and compliance procedures;

+ Review, approve and supervise all aspects of clinical study safety programs, including preparation of case report forms, study reports, safety statistical analysis plans, and data management plan;

+ Ensure final accuracy of all clinical trials safety data and its timely availability, in an agreed format;

+ Oversee management of any GCP compliance issues and assure appropriate communication, issue resolution and adherence to SOPs and guidelines; ? Develop and implements the appropriate safety and compliance procedures for clinical trials, including staff and contractor training;

+ Support site qualification, site initiation, monitoring, site close out activities, by reviewing respective reports in accordance with clinical safety and compliance procedures; ? Work closely with Regulatory Affairs in the generation of FDAs Annual Progress Reports as well as safety reports as required by the IRB or EC, Ministry of Health, and other governing agencies;

+ May conduct periodic audits of clinical vendors (i.e. core laboratories, translators, clinical research organizations);

+ Participate in FDA BiMo inspections and other regulatory inspections of clinical studies;

+ Demonstrate strong interpersonal skills and ability to independently confront issues for a win-win outcome;

+ May be asked to perform other Clinical responsibilities as needed.





JOB REQUIREMENTS:



Education and Training



Bachelors or advanced degree in Nursing, Life Sciences or other technical discipline.



Technical Requirements



Candidate must have minimum of 7 years medical device industry experience with at least 5 years of focus on safety and compliance, and prior experience with Class II/III implantable devices. Prior orthopedic medical device experience is preferred.



Strong knowledge and competence in application of CFRs, GCPs, ICH Guidelines, ISO 14155, and Statistics required. FDA inspection experience is a plus. Candidate must demonstrate proficiency in required software and computer skills. Candidate must demonstrate excellent written and verbal communication/ presentation skills to meet the needs of various audiences. Strong team leadership experience and motivational skills are essential.



The Manager of Safety and Compliance may travel approximately 20% each year.














**Why Kelly** **** **?**



With Kelly, youll have access to some of the worlds highest-regarded scientific organizations
providing you with opportunities to work on todays most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits youll be proud to help
advance. We work with 95 of the Fortune 100 companies, and found opportunities for more than 9,000
scientific professionals last year.


You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your careerconnect with us today.




**AboutKelly Services** ****



As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.
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