Associate, Monitoring Oversight

4 weeks ago

Bengaluru, India Lilly Full time

We’re looking for people who are determined to make life better for people around the world.

Purpose:

The purpose of the Associate, Monitoring Oversight role is to be an advocate for monitoring oversight who works with the Clinical Design, Delivery & Analytics (CDDA), the Medicines Quality Organization (MQO) and Investigator Engagement (IE) to ensure that Lilly has appropriate oversight of clinical trial site monitoring activities outsourced to Third Party Organizations (TPOs).

Primary Responsibilities: This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.

Conduct Monitoring Visit Report Reviews (MVRRs)

Collate output from multiple data sources and conduct site risk assessments Identify sites to be selected for MVRRs based on a predefined set of risk criteria Prepare documentation for MVRR reviewReview a sampling of Monitoring Visit Reports (MVRs) produced by TPO Clinical Research Associates (CRAs) following the conduct of monitoring visits at clinical trial sitesIdentify any MVR issues, gaps and required next steps and document this information in a MVRR ChecklistRecord identified MVR issues in the Clinical Trial Management SystemFollow-up with TPO CRA to ensure that any required follow-up actions are completed in a timely mannerCommunicate key detected issues and required next steps to the CRL and/or CDTL for the trialResponsible for Inspection Readiness activities in relation to the MO process

Escalate Significant Identified Monitoring Oversight Issues

Communicate significant monitoring oversight issues detected during MVRRs to the CRL and/or CDTL for the trial Follow-up as needed with the CRA, TPO Management and Lilly Study Teams to discuss the steps required to resolve the detected significant monitoring oversight issues

Identify Monitoring Oversight Trends

Identify and track any monitoring oversight trends that are occurring across sites monitored by the same CRA or across multiple sites or studies monitored by the same TPO Discuss any detected monitoring oversight trend(s) with the Monitoring Oversight Business Lead and Medical Quality to determine the next steps required to address the trend(s)
 

MVRR Performance Metrics and Process Metrics

Identify and track relevant monitoring data to support monitoring oversight of MVRRs Follow-up as needed with Lilly Site Engagement and TPO management to discuss the steps required to resolve the detected MVRR performance metrics and process metric issues

Minimum Qualification Requirements:

Bachelor’s Degree in a science, technology or medically-related field or equivalent relevant work experience At least 2-3 years of clinical research related experience Knowledge of Good Clinical Practices (GCP) Principles Proficient written and spoken English language skills Effective verbal communication

Other Information/Additional Preferences:

Ability to work independently and as part of a team Previous on-site/remote CRA or monitoring report review experience Effective organization/self-management skills Excellent problem-solving skills and initiative

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

#WeAreLilly

  • Associate, Monitoring Oversight

    6 days ago

    Bengaluru, Karnataka, India Lilly Full time

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...

  • Gss Inter Affiliate Oversight Associate/avp

    4 weeks ago

    Bengaluru, India JPMorgan Chase Bank, N.A. Full time

    The Inter Affiliate Services team is a centralized group within Global Supplier Services that manages the Inter Affiliate Oversight & Governance function for several different Corporate Functions in the regions. This group provides consistent monitoring of all Inter Affiliate activity between JPMC legal entities in order to ensure compliance to the Inter...

  • Inter Affiliate Oversight Associate, Bangalore

    7 days ago

    Bengaluru, India JPMorgan Chase Bank, N.A. Full time

    The Inter Affiliate Services team is a centralized group within Global Supplier Services that manages the Inter Affiliate Oversight & Governance function for several different Corporate Functions in the regions. This group provides consistent monitoring of all Inter Affiliate activity between JPMC legal entities in order to ensure compliance to the Inter...

  • Associate - Oversight Operations - Sourcing Desk

    1 week ago

    Bengaluru, India JPMorgan Chase Bank, N.A. Full time

    Firm-wide Supplier Oversight Services (SOS) is a centralized group that manages the Third Party Oversight & Governance function across JPMC. This group provides consistent monitoring of all Third Party activities in order to ensure compliance to the Third Party Oversight (TPO) standards and Global Technology Standards. Within Firm-wide SOS, the Oversight...

  • Associate - Supplier Oversight Services (Third

    7 days ago

    Varthur, Bengaluru, Karnataka, India JPMorgan Chase & Co Full time

    **JOB DESCRIPTION** Firm-wide Supplier Oversight Services (SOS) is a centralized group that manages the Third Party Oversight & Governance function across JPMC. This group provides consistent monitoring of all Third Party activities in order to ensure compliance to the Third Party Oversight (TPO) standards and Global Technology Standards. Within Firm-wide...

  • Associate Third Party Oversight, Bangalore/ Mumbai

    4 weeks ago

    Bengaluru, India JPMorgan Chase Bank, N.A. Full time

    Firm-wide Supplier Oversight Services (SOS) is a centralized group that manages the Third Party Oversight & Governance function across JPMC. This group provides consistent monitoring of all Third Party activities in order to ensure compliance to the Third Party Oversight (TPO) standards and Global Technology Standards. Within Firm-wide SOS, the Oversight...

  • Associate - Oversight Operations

    4 weeks ago

    Bengaluru, India JPMorgan Chase Bank, N.A. Full time

    End to End engagement brokering for Onboarding commercial activities as per the TPO Program for acqiured company's supplier engagements - Ensure all TPO activities within the portfolio are delivered in a manner consistent with TPO policy and regulatory guidance across all risk engagements - Acts as TPO Process and Tool SME for the business Delivery Managers...

  • Product Change

    4 weeks ago

    Bengaluru, India The Edge Partnership Full time

    Key responsibilities Lead product change initiatives, including new product submissions and updates to existing products. Manage business-as-usual (BAU) change processes to ensure smooth transitions and minimal disruption. Drive product development and change initiatives, oversee BAU change management activities, conduct data collation and analysis,...

  • Process Associate- Call Monitoring

    4 days ago

    Bengaluru, India Recex Full time

    **Opening**: 1 Nos.**Job ID**: 66779**Employment Type**: Full Time**Reference**: **Work Experience**: 3.0 Year(s) To 5.0 Year(s)**CTC Salary**: 4.00 LPA TO 7.00 LPA**Function**: Accounts / Finance / Tax / CS / Audit**Location**: Bengaluru/bangalore Mumbai **Posted On**: 24th Aug, 2023 Call Monitoring FTE is responsible for assessing the performance of the...

  • Investment Risk Associate

    4 weeks ago

    Bengaluru, India WELLS FARGO BANK Full time

    **About this role**: Wells Fargo is seeking an Investment Risk Associate... **In this role, you will**: - Provide focused oversight of significant fiduciary and investment risks for the company and its customers. Responsible for measuring and analyzing the client's portfolio risk, model portfolio risk, fiduciary and investment related product risk, and...

  • Associate Manager, Compliance Testing and Monitoring

    2 weeks ago

    Bengaluru, India PhonePe Full time

    About PhonePe Group:  PhonePe is India’s leading digital payments company with 50 crore (500 Million) registered users and 3.7 crore (37 Million) merchants covering over 99% of the postal codes across India. On the back of its leadership in digital payments, PhonePe has expanded into financial services (Insurance, Mutual Funds, Stock Broking, and...

  • External Monitoring Group

    3 weeks ago

    Bengaluru, India F335 Deutsche India Private Limited, Bangalore Branch Full time

    Description The External Monitoring Group (EMG) is an independent Level 1 control function performing trading surveillance across the Bank. Located within Financial Crime Risk Compliance Business Control Oversight - (FCRC-BCO), EMG is closely aligned with front office whilst maintaining segregation to perform a review and challenge control –...

  • VP- Fraud Monitoring

    4 weeks ago

    Bengaluru, India First Abu Dhabi Bank Full time

    Job Description Job Purpose: The Group Fraud Risk & Investigations function is part of the group’s Risk Management function and provides second line Fraud Risk oversight for the firm’s front office and support / control functions. The role of the VP Fraud Monitoring entails leading and establishing a team of Fraud alert Analysts operating on a...

  • Compliance-Bengaluru-Associate-Market Surveillance

    7 days ago

    Bengaluru, India Goldman Sachs Full time

    Our division prevents, detects and mitigates compliance, regulatory and reputational risk across the firm and helps to strengthen the firm’s culture of compliance. Compliance accomplishes these through the firm’s enterprise-wide compliance risk management program. As an independent control function and part of the firm’s second line of defense,...

  • Analyst- Fraud Monitoring

    4 weeks ago

    Bengaluru, India First Abu Dhabi Bank Full time

    Job Description Job Purpose: This role is responsible to support Fraud Risk Monitoring by reviewing alerts generated by fraud prevention & monitoring systems to prevent and detect frauds Key Accountabilities: Core Responsibilities Review and conclude alerts generated by fraud prevention/monitoring systems Continue to monitor current trends...

  • Fund Accounting

    4 weeks ago

    Bengaluru, India State Street Full time

    Manage the day-to-day activities of a functional/oversight team by monitoring, reviewing and validating all daily activity to ensure accuracy and timeliness in calculations and processing, as well as adherence to controls, e.g. ensuring accurate g/l and/or balance for daily pricing - Provide timely accurate management reporting and issue log maintenance,...

  • Portfolio Monitoring and Reporting

    7 days ago

    Bengaluru, India Apex Group Full time

    Portfolio Monitoring and Reporting Location: Bangalore, India Date Posted: Apr 13, 2023 **Description** - Portfolio Monitoring and Reporting team - Alternative Investments, Private Equity**Employment Type (full time)**: ***Associate / Senior Associate / AVPThis is an excellent opportunity for a highly motivated professional to join our global...

  • Senior Associate

    2 weeks ago

    Bengaluru, India Randstad Full time

    Open roles: Senior Associate 1 & Senior Associate 2Role - SA1Exp - 4 to 6 yearsLocation - Bangalore / HyderabadSkills - ITGC, SOX, SOC, TOD, TOE + External auditRole - SA2Exp - 6 to 8 yearsLocation - Bangalore / HyderabadSkills - ITGC, SOX, SOC, TOD, TOE + External auditCurrent or previous Big4 experience is a must. (For SA2/ Senior associate 2 only)Job...

  • Senior Associate

    2 weeks ago

    Bengaluru, India Randstad Full time

    Open roles: Senior Associate 1 & Senior Associate 2Role - SA1Exp - 4 to 6 yearsLocation - Bangalore / HyderabadSkills - ITGC, SOX, SOC, TOD, TOE + External auditRole - SA2Exp - 6 to 8 yearsLocation - Bangalore / HyderabadSkills - ITGC, SOX, SOC, TOD, TOE + External auditCurrent or previous Big4 experience is a must. (For SA2/ Senior associate 2 only)Job...

  • Senior Associate

    2 weeks ago

    Bengaluru, India Randstad Full time

    Open roles: Senior Associate 1 & Senior Associate 2 Role - SA1 Exp - 4 to 6 years Location - Bangalore / Hyderabad Skills - ITGC, SOX, SOC, TOD, TOE + External audit Role - SA2 Exp - 6 to 8 years Location - Bangalore / Hyderabad Skills - ITGC, SOX, SOC, TOD, TOE + External audit Current or previous Big4 experience is a must. (For SA2/ Senior associate 2...