Job: Clinical Operations Safety Manager

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Jobing Description

The Clinical Operations Safety Manager is responsible for providing daily support to the Clinical Study Teams in the management of all aspects of the safety letter distribution process.   The Clinical Operations (CO) Safety Manager is responsible for centralization, distribution, tracking and quality control of the safety information which is submitted to investigational sites and Ethics Committees across all compounds.   He/she must be able to manage multiple tasks independently or with minimal supervision .   He/she will oversee safety letter distribution to vendors and/or clinical study sites for all active clinical studies, including leading or participation in the development and documentation of the safety letter distribution process, regular and timely reconciliation of safety letter distribution, vendor communication and oversight as related to safety letter distribution, as well as assisting with training of internal and external parties. He/She will be responsible for representing CO in meetings with Global Patient Safety (GPS) and regulatory inspections. He/She will be responsible for identifying process improvements and gathering metrics on an ongoing basis to further analyze issues.   Furthermore, he/she may be responsible for managing safety letter related start-up activities (compile and distribute gap packs for clinical study sites, distribution of Investigator Brochures, etc.).

Job Duties:
*Demonstrates a working knowledge of ICH GCP regulations and clinical protocols
*Able to proactively identify project challenges/risks and implement appropriate actions with some supervision
*Strong communication (written and verbal) skills
*Works independently to accomplish individual and department objectives within deadlines
*Ability to independently identify problems and effectively offer solutions
*Ability to prioritize workload and complete work/deliverable effectively and within timelines
*Demonstrated computer literacy; proven functional knowledge of Microsoft packages and ability to develop proficiency in relevant Vertex systems and programs

Responsibilities:
*Maintains central repository of safety information across all active compounds *Ensures distribution of safety information to investigational sites, IRBs and Ethics *Committees per regulatory timelines, either through CRO or working directly with site as in the case of studies held at Phase 1 units.
*Establishes tracking tools to support Clinical Operations members in verifying that all required safety information has been correctly distributed to investigational sites
*Provides quality control of the process for safety information distribution to investigational sites to ensure consistency, including generation of compliance metrics, generation of reports from Intralinks, identification of process gaps and proposals for solutions
*Provides compliance and quality metrics
*Prepares, contributes, and assists as subject matter expert with writing and maintaining standard operating procedures and guidelines for safety letter distribution
*Actively participates in vendor management and oversight
*Supports Clinical Operations members in ensuring relevant safety information documentation is submitted to the Trial Master File
*Working with the Clinical Operations members maintains all contact lists utilized to distribute safety information
*Creates necessary training materials and takes the lead in training Clinical *Operations members, CRO teams, and investigators and staff as needed regarding safety information
*Maintains the Investigator Brochure 'gap pack' for all active compounds and supports Clinical Operations members in start-up to ensure accurate safety information is provided to investigational sites, IRBs and Ethics Committees
*Evaluates process on an ongoing bases by analyzing metrics and recommending process improvements
*Performs other duties as assigned

Skills / Requirements

Minimum Qualifications:
* B.S. in a scientific or allied health field and a minimum of 7 years of relevant work
experience in the Biotech or Pharmaceutical Industry or MS in a scientific or
allied health field and a minimum of 5 years of relevant work experience in the
*Biotech or Pharmaceutical Industry.

Preferred Qualifications:
*Excellent knowledge of drug safety and the drug development process

*Experience in data analysis, evaluation of safety data and the preparation of
safety reports

*Ability to train and mentor people

*Ability to work with cross functional teams

*Excellent presentation skills

*Excellent interpersonal skills

*Excellent verbal / written communication skills

*Excellent time management skills

*Experience with computer applications including database management and
pharmacovigilance related computing systems


Vertex creates new possibilities in medicine. Our team discovers, develops and commercializes innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases. Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the United States, United Kingdom and Canada. Vertex has consistently been recognized as one of the industry's top workplaces by leading publications such as Science Magazine, The Boston Globe, Boston Business Journal, San Diego Business Journal and The Scientist, and most recently was named the top employer in Science magazine's 2011 annual survey.

VERTEX is an Equal Opportunity/Affirmative Action employer. All employment decisions are made without regard to race, sex, national origin, color, religion, age, disability, veteran status or any other status protected by applicable law.