Clinical Safety Data Manager

Clinical Safety Data Manager

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Job Description

The Manager, Safety Data Collection, Clinical Trials is responsible for managing the Pharmacovigilance (PV) operations of Pre and Post-approval Clinical Studies globally. The employee supports the Senior Manager, Safety Data Collection, Clinical Trials and is responsible for setting the safety operations strategy, establishing the safety report collection standards and processes, and ensuring they are implemented and executed consistently throughout all Pre and Post-Marketing Clinical Studies globally. The AE Intake Clinical Trials Associate will provide partner / vendor oversight in relation to Clinical Trial safety report collection and will collaborate with other functions (e.g., Clinical Operations, Medical Affairs, Data Management, Medical Writing, Regulatory, Biostatistics, and others) to ensure consistency with regulations and with departmental goals and objectives. Where relevant, when partners (e.g. Quintiles Strategic Partnership) have additional safety related responsibilities, the manager ensures proper coordination between the partner and the SABR Subject Matter Expert/function lead.

Support Senior Manager, Safety Data Collection, Clinical Trials with setting the safety operation strategy and establishing the safety report collection standards and processes for Pre and Post-approval Clinical Studies globally Senior Manager, Safety Data Collection, Clinical Trials 20%

Execute the development, maintenance and implementation of Controlled documents (SOPs), data handling conventions and other process documents for Clinical Trials and Post-Marketing Clinical Studies

Safety operational content and processes for Clinical Trial and Post-Marketing Clinical Study tools for report collection such as protocols, CRFs, SAE forms, Pregnancy forms

Tools and processes for database requirements and configurations to enable safety-related activities during studies

Training requirements and materials for Clinical Trial safety report collection Senior Manager, Safety Data Collection, Clinical Trials 20%

Oversee and ensure study safety operational requirements are operationalized Senior Manager, Safety Data Collection, Clinical Trials 15%

Support the following Strategic Partner / vendor oversight activities, in conjunction with relevant functions (such as Global Clinical Operations) in relation to Clinical Trial safety report collection:

Provide functional support / input to set up partner and vendor relationship (e.g., business requirements, vendor selection, contract details, vendor oversight / safety management plans)

Support onboarding and ongoing maintenance of partner and vendor status to perform work (e.g., access, training, technology set-up)

Provide ongoing support of partners and vendors (e.g., questions, issues, meetings)

Conduct partner oversight and performance management on contracted work (e.g., monitoring reports, quality evaluations, annual meetings) Senior Manager, Safety Data Collection, Clinical Trials 20%

Communicates on PV legislation and regulatory commitments across the organization and externally Senior Manager, Safety Data Collection, Clinical Trials 5%

Acts as subject matter expert on Pharmacovigilance (PV) operations of Pre and Post-Marketing Clinical Studies during audits / inspections Senior Manager, Safety Data Collection, Clinical Trials 10%

Qualifications

Education & Experience Required:

Bachelor's level degree in nursing, pharmacy, or other health care related profession or life sciences required

Master's or Doctorate level degree in health care related profession preferred

4+ years in drug safety/Pharmacovigilance in pharmaceutical industry setting or the equivalent

Experience interacting with clinical third parties (e.g., contract research organizations) preferred

Knowledgeable in Pharmacovigilance and GCP legislation required

Direct experience in GXP compliant quality systems preferred

Excellent written and verbal communication skills including: technical writing skills, PC skills, ability to produce clear, concise documentation and good analytical skills

Must work effectively/collaboratively in a fast-paced team environment and with individuals at all levels within an organization

Effective managerial skills, being a self-starter, ability to work independently, goal oriented, attention to detail and accuracy, and ability to multi-task and prioritize

Ability for individual decision-making required

Must demonstrate initiative to identify and communicate issues within department and across departments