Manager Data Management

• We’re on a mission to change the future of
• clinical research. At Perceptive, we help the
• biopharmaceutical industry bring medical
• treatments to the market, faster.
• Our mission is to change the world
• but to do this, we need people like you.

Apart from job satisfaction, we can offer you:

HEALTH:

- Medical plan for you and your dependents.

- Personal Accident Insurance

- Life Insurance

- Critical illness cover

WEALTH:

- Salary structure and Flexi basket

- Provident fund of 12%

- Gratuity scheme

YOURSELF: Internal growth and development programs & trainings

As Manager, Clinical Data Management, you will oversee and work alongside a team of end-to-end data custodians and will play a key role in managing data and ensuring its accuracy, completeness, and compliance with regulatory standards while providing data management support to study teams. In this role, you will create data management standard operating procedures and help define overall process and training for Clinical Data Management staff in accordance with SCDM best practices and applicable regulatory requirements. This is a working manager position requiring strong managerial and interpersonal skills alongside hands-on application of skills.

Key Responsibilities

Leadership and Team Management

• •Leads, mentors and develops a clinical data management team through direct line management.
• •Provides training on Data Management procedures.
• •Provides training and monitors performance to ensure the team are operating at the highest level to design and deploy clinical databases for multiple clinical imaging studies.
• •Managing project timelines, resources, and deliverables to ensure timely and successful completion.
• •Acts as resource manager for dedicated therapeutic area.
• •Sets clear goals, providing regular feedback and fostering a collaborative team environment.
• •Conducts one-on-one meetings.
• •Mentors and ensures the team adheres to best practices and industry standards and facilitates positive career growth.
• •Driving the adoption of new tools and technologies to enhance data management capabilities.

Data Management

• •Excellent understanding of industry-recognized data structures and standards (CDISC (SDTM), CDASH) and custom client specified formats.
• •Provides guidance as clinical database development subject matter expert.
• •Monitors study timelines and communicates risk.
• •Acts as sponsor portfolio lead representative.
• •Oversees multiple concurrent projects.
• •Communicates with sponsors and internal leadership regarding study data processes, endpoints, and overall data management process.
• •Creates standards for the validation of data management programs and reports (data reconciliation, data quality monitoring checks, export, reviewer metrics and custom reports).
• •Provides best practices on review and action of any data discrepancies or flags from data reconciliation, data quality monitoring reports, data exports and reviewer metrics.
• •Excellent understanding of the context of the data (awareness of Therapeutic Areas (TA) (oncology, cns, ophthalmology, volumetrics etc.) and how data differs based on the specific criteria (RECIST 1.1, irRECIST, mRECIT, Lugano, Cheson etc.)
• •Provides expert advice and guidance to enable the organization to get maximum value from its data assets.
• •Seek to automate data management activities where possible.
• •Develop processes to enable good data management practices and compliance with data governance policies.

Process Oversight

• •Creates and maintains Standard Operating Procedures.
• •Provides guidance on Data Management best practices and regulatory considerations.
• •Defines new procedures and solutions for novel therapeutics and
• •study endpoints.

Data Oversight

• •Advocate data governance and data management standards and guidelines within data management team.
• •Understand data issues and can check that the data and analysis look right.
• •Deep understanding of relevant data sources, tools and systems
• •Use appropriate approaches for verifying and validating data and analysis.
• •Influence senior stakeholders in data approaches.
• •Coach and mentor others.
• •Validate the collected data, ensuring its accuracy and reliability.
• •Identify appropriate ways to collect, collate and prepare data.
• •Ensure data is appropriately stored and archived, in line with relevant company’s policies and procedures.
• •Apply ethical principles when handling data.
• •Peer review associate DM and DM outputs to ensure quality.
• •Communicates the limitations of data.
• •Set up a system to get data ready for use and specify how data should be cleansed and prepared.

• •Create and review all relevant documentation for data management activities (data reconciliation and analytics, export requirement specification, data management plan, software change requests, reviewer metrics etc.)
• •Listen to the needs of technical and business stakeholders and interpret them creating relevant documentation.
• •Understand protocol, charter, and analysis wireframes.

Documentation

• •Create and review all relevant documentation for data management activities (data reconciliation and analytics, export requirement specification, data management plan, software change requests, reviewer metrics etc.)
• •Listen to the needs of technical and business stakeholders and interpret them creating relevant documentation.
• •Understand protocol, charter, and analysis wireframes.

Other

Carries out any other reasonable duties as requested.

Communication

• •Effectively manage stakeholder expectations.
• •Manage active and reactive communication.
• •Attend the client calls and communicate effectively with external stake holders (clinicians, data management and biostatisticians) in resolving data quality questions.

Functional Competencies (Technical knowledge/Skills):

• •Excellent demonstrable knowledge of regulatory guidelines and requirements for clinical data management.
• •Displays excellent understanding of clinical trial data standards.
• •Understanding of clinical trial processes, protocols, and regulatory requirements (e.g., FDA guidelines) related to data management.
• •Excellent communication (oral and written) and interpersonal skills, to convey data-related information to technical and non-technical stakeholders (internal and external) including clients and research centres.
• •Excellent analytical skills with attention to detail and the ability to identify data discrepancies and trends.
• •Ability to manage multiple tasks and prioritize work in a fast-paced and deadline-driven environment, with the ability to raise potential issues with deliverables on time.
• •Detail oriented and possess excellent organizational skills.
• •Builds and maintains an up-to-date awareness of industry trends, best practices, and emerging technologies in data management for clinical research.
• •Ability to work collaboratively within a matrix team environment.
• •Ability to effectively motivate and guide team members towards shared goals.
• •Natural coach/mentor who leads by example with an approachable demeanour and visible leader skills.
• •A self-starter and able to work under own initiative.
• •Strong analytical and creative problem-solving skills to identify issues and propose solutions.
• •Displays technical project management skills and oversight.
• •Ability to manage task creation and tracking via ticketing software.
• •Demonstrates meticulous attention to detail, documentation and adherence to study protocols and standard operation procedures (SOPs).

Experience, Education, and Certifications:

• •Significant demonstrable practical work experience in a clinical or technical setting.
• •Line management experience.
• •Demonstrable experience in team settings to achieve goals.
• •Demonstrable experience and proficiency with clinical data management systems.
• •Experience working with research support or clinical team.
• •Proficiency in Microsoft Office Suite (Word, Excel (macros), PowerPoint) and data visualization too