Oversight Manager

The oversight manager will be responsible to evaluate the quality of the monitoring activities to ensure that the rights and well-being of human subjects are protected, implement remedial activities, when necessary, receive feedback from the site on all aspects of study operations, ensure the site is inspection ready, and further establish/improve relationships between Endo and the site.  Oversight Manager will also help with oversight of Endo’s vendors and clinical studies.

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

§  Develop SOP(s) as needed around oversight activities  

§  Identify sites selected for monitoring oversight visit (MOV)

§  Work closely with the R&D Strategy and Operations teams to identify sites to be selected for MOV

§  Author the study specific Monitoring Oversight Plan

§  Conduct Oversight Visits which includes but not limited to review SDV previously completed by CRA, check IP accountability, review CRA queries, review investigator site file, meet with site staff, evaluate quality of monitoring, and evaluate CRA performance

§  Complete report following MOV

§  Escalation of monitoring and quality issues

§  Work with study team on improvements for monitoring/quality issues

§  Perform TMF QC Checks

§  Develop and perform training to improve quality of monitoring

§  Perform site calls to Endo investigative sites to build relationships and help the study teams with escalation/resolution

§  Perform routine Health Assessments to evaluate the health  of ongoing clinical studies

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Monitoring Oversight

§  Conduct MOVs

§  Evaluate CRA performance

§  Evaluate quality of monitoring

§  Work with sites/study team to ensure sites are inspection ready

§  Work with study team and implement improvements for monitoring/quality issues

40%

General oversight

§  Health Assessments

§  OSC/ESC attendance/preparation for preferred vendors

§  Site Calls

30%

Training

§  Develop/conduct training to help increase monitoring & vendor quality

§  Develop tools needed to improve monitoring quality

§  Develop training/tools for sites to prepare for site audits

30%

Total

100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and  certifications required for the job

§  College degree or RN or higher, preferentially in sciences/medical sciences

§  Minimum of 5 years of clinical monitoring experience

§  Minimum of 8 years of experience in pharmaceutical industry or clinical research site based experience

§  Previous experience managing/overseeing/mentoring CRAs

§  Previous experience developing training/training CRAs

Knowledge

Proficiency in a body of information required for the job e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

§  Well versed in GCP and applicable FDA/EMEA/ROW regulations

§  Broad and deep understanding of monitoring for clinical trials domestically and globally

§  Knowledgeable in the interaction between functional areas as well as at site level

Skills

&

Abilities

Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific       e.g. coaching, negotiation, calibration, technical writing etc.

§  Proficient in written and oral communication and experience in presenting to groups.

§  Ability to work with clinical trial and clinical data management systems,  MS Office,  electronic document management and other web-based systems.

§  Works autonomously under consultative direction toward long range goals.

§  Communicate proactively and appropriately and various levels within the organization and externally.

§  Anticipate problems and innovate effective plans for complex situations.

§  Partner with colleagues to build and maintain strong, collaborative relationships across functional areas within Endo, with Endo alliance partners and external service providers.

§  Ability to prioritize and manage multiple tasks; strength in organization and planning.

§  System experience (e.g., EDC, CTMS, eTMF, IRT)

Physical Requirements

Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

§  Standard office environment and daily commute to assigned office location or regionally based.

§  Business travel ~50%.

https://www.endo.com/