Protocol Data Manager - L9 - Bangalore

Job Description:

Job Role: Senior Protocol Data Manager

Purpose/Objective of the role:

The Senior PDM position supports data management tasks for maintenance through database lock and submission.  Sr. PDMs are segregated into teams supporting either study startup or review to lock tasks/processes to ensure efficiency and quality throughout the life of the clinical trial. 

Key responsibilities of the role:

• Demonstrates a strong understanding of the overall project goals, the indication studied and the purpose of the assigned study in meeting the objectives of the project. Responsible for data management review to lock activities of assigned protocols and independently overseeing database update process. Answers and resolves routine data related questions independently.
• Responsible for proactively identifying and resolving issues noted during data management which impact the overall timelines and informs the appropriate Client team members (e.g. Clinical Site Managers, Protocol Manager, Site Monitor, Medical Encoders, eClinical Support & Submissions, Data Leads, Global Pharmacovigilance) and coordinates follow-up.
• Engages the Data Lead and/or Protocol Manager to assist in the resolution of more complex issues. Understands how the issues of a single study can impact the overall project.
• Provides feedback and status updates to internal stakeholders on an ongoing basis. In collaboration with Site Manager and Site Monitor, serves as a Client contact with the Investigator Site for any data related issue. Presents data related issues to team members and drives resolution to ensure that data management activities are in compliance with global and Program level standard requirements, study timelines, ICH-GCP guidelines, Client SOPs and regulatory guidelines or regulations.
• Assists with vendor relations (e.g., CRO; CCL) as needed to support the incumbent’s project(s), e.g., participation in monthly vendor meetings to discuss project issues.
• Participates as an active member of cross functional teams or initiatives.
• Responsible for the development of data review plan and processes for data management that can be easily accessible by all protocol team members. Possesses a strong knowledge of Clinical Study Report concepts and applies them for defining tools for data clean-up and defining plan for completing database lock activities. Collaborates with the Data Lead to develop standards and ensure consistency and efficiency of the clinical protocols within indication or program for data cleaning reports.
• Participates in the recruitment and interview process of new protocol data manager candidates
• Coordinates/develops the initial and ongoing data related training of Investigators, site personnel, vendors, Client team etc., for data related issues and collaborates with other PDMs and the Study Team to ensure training is consistent across all protocols within a program. Provides on-going training and mentoring to team members through a mentoring process using informal and/or formal presentations. Contributes to the formal training of new personnel and serves as a resource for colleagues, identifying development opportunities. Contributes to the establishment of best practices through coaching and feedback
• Skilled in the use of technology. Can function independently in addition to coaching other team members within an environment that relies heavily on this knowledge for information and communication. Effectively uses available tools (e.g. J-Review, Study Management Tools, Oracle Clinical/RAVE) to gather information needed to manage study activities, generate reports and to provide feedback to Protocol Manager and Medical Monitor
• Responsible for the development of data review plan and processes for data management that can be easily accessible by all protocol team members. Possesses a strong knowledge of Clinical Study Report concepts and applies them for defining tools for data clean-up and defining plan for completing database lock activities. Collaborates with the Data Lead to develop standards and ensure consistency and efficiency of the clinical protocols within indication or program for data cleaning reports.
• Oversees study level data management activities for assigned protocols (e.g. data management metric tracking, reviewing data listings and tables, monitoring query flow and receipt of external data, overseeing discrepancy management). Answers and resolves routine data related questions.   Effectively uses available tools to gather information needed to manage study activities, to write and/or generate reports, and to provide feedback to appropriate study team members.       
• Oversees and manages the identification and resolution of data management issues which impact timelines.  Communicates and resolves data issues with vendor staff and Clinical Team as appropriate.  Uses appropriate escalation pathway to inform the appropriate team members of problems and potential solutions.
• Responsible for the database lock process. Coordinates and drives the completion of all database lock activities to the standards expected, ensuring effective use of resources. Communicates resource needs that may pose potential risk to time lines (e.g. outstanding SAE queries, delays in external files), and suggests contingency plans if needed. Acts as a source of knowledge for database lock activities and resolves issues arising at time of database lock independently.
• Serves as a primary interface to Contract Research Organizations (CROs) on all database management activities
• If oversees a life-cycle drug program, may supervise, from a project perspective, activities of other Protocol Data Managers
• During a study evaluates the benefits provided by existing tools or the need to request new or updated data review tools
• Responsible for the development of a project management plan and processes for data management that can be easily accessible by all protocol team members. Provides leadership to the protocol team for data management activities in complex protocols, identifying potential issues and risks to the plan and taking pre-emptive action
• Manages matrix relationships with other study team members. Provides feedback and status updates to protocol team members on an as needed basis.  Proactively identifies and presents data related issues to PDM and team members to help ensure data management review to lock activities follow required standards (i.e. global and program level standards, ICH-GCP guidelines, Client SOPs and regulatory guidelines or regulations).
• Contributes to the establishment and/or development of best practices through coaching and feedback. Helps ensure best practices are shared and common issues communicated to key stakeholders to support consistency within a protocol or program and/or role.
• Participate as an active Senior PDM representative in cross functional teams.
• Adheres to policies and practices as specified around masked data in clinical trial.

Required Educational Background:

• Bachelor’s degree preferred in one or more of the following disciplines or related fields: Life Sciences and Allied Healthcare professionals.

Required Software Tool Competencies:

• Basic office tools (e.g. MS Suite); CDMS (e.g. Medidata Rave, Oracle Clinical, INFORM etc..); J-Review; SAS programming will be a plus.

Required Experience & Competencies:

• 6-7 years of extensive experience as a Protocol Data Manager or equivalent in the pharmaceutical industry; experience supporting review of laboratory data a plus.
• Experience negotiating with and influencing others to meet challenging goals. Must be self-motivated, with the ability to follow through on assignments without direct supervision, very attentive to detail, capable at multitasking across projects and able to effectively contribute in a team environment.          
• Experience working with vendors who supply clinical data in electronic format.
• Strong analytical skills to facilitate detecting and resolving data problems encountered in clinical research studies
• Previous experience using project management techniques including prioritization methods and the ability to work on different projects simultaneously.
• Previous experience working in a team environment within a matrix organization.
• In depth knowledge of clinical research including Investigator site issues, important milestones and strategies to ensure timelines are met.
• Experience in effective implementation of data review/management plans/documents and document preparation.
• Experience in all aspects of data management from CRF design to database lock within expectations set by management.
• Experience in training less experienced data managers in system and study specific areas.
• Knowledge of data review processes and Database Management Systems including eDC systems.
• Knowledge of ICH-GCP guidelines regulatory guidelines/regulations.
• Solid understanding of regulations, GCPs, 21CFR Part 11 and data privacy as they apply to data handling and the use of computer systems in clinical research.
• Knowledge of general clinical research including Investigator site processes.
• Knowledge of the pharmaceutical industry including the clinical and regulatory components.
• Knowledge of basic project planning and management methods.