Opella→
Data Manager at Opella in Hyderabad, Telangana, IN
Skills
Job Description
Job title: Data Manager
- Location: Hyderabad
Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.
Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting.
At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.
As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at http://www.opella.com.
About the job:
The Data Manager is responsible for leading, coordinating, controlling and overseeing the end-to-end quality deliverables of data management activities for clinical/RWE and nonclinical evidence studies.
Main responsibilities:
DM liaises directly with internal customers (Global Study Managers, Study Medical Manager, Statistical Programmer, Risk Based Monitoring, Pharmacovigilance, Quality, etc.) to lead all data management and eTMF management activities for assigned study.
Involved, as Contributor, in Study Outline (SO) preparation and Protocol review, Study Risk Management Plan, SAE reconciliation, deviation review, data review, medical review, data surveillance and other review activities during the conduct of the study.
Managing, controlling and overseeing service providers (CROs) independently on data management activities and maintains a good working relationship with the vendor:
- Controlling and overseeing any data management activities performed by a DM role vendor.
- Reviewing vendor qualification and vendor proposal and contract for inclusion of appropriate scope of work, pricing and agreed services. Obtains appropriate approval for scope of work and budget update. Reviews and approves vendor invoices based on the contract. Ensures all vendor contract related documents are processed on-time.
- Performs assessment of vendor performance trends and service risks.
- Meets regularly with vendor representatives to control quality and implement mitigation actions; proposes solutions for data management issues that arise during the conduct of a study and monitor until resolution.
- Verify planning of all data management activities, considering the overall study timelines and ensuring DM activities are conducted as planned.
- Reviewing and approving DM study deliverables, such as eCRFs, annotated CRFs, CRF Completion Instructions, Electronic Data Capture (EDC) system, Centralized Monitoring Plan, Data Management Plan, Data Validation Specifications, Data Review Listings/Reports as per company standards and protocol requirements. Controls data collection quality: assures that data management standards are followed and verifies the study data cleaning and validation strategy integrating risk-based approach.
- Regular review and quality control of study data management activities status for data entry and data cleaning, preferably by direct access to eCRF or by receiving reports from CRO DM.
- Verifying, controlling, overseeing any external data activities: load, integration activities and reconciliation activities, including final clinical database transfer from the vendor to Opella, external Lab data, IRT integration etc.
- Participating, controlling and overseeing data transfer specific meetings with the CROs/vendors and -if required- in Investigator Meetings and other outside meetings.
Managing all TMF activities for all studies (clinical and nonclinical) with the CRO:
- Reviewing and approving TMF key documents, such as TMF plan, TMF Transfer Plan. Assures that TMF standards are followed.
- Discuss and agree on management of TMF transfer with CRO depending on CRO TMF system.
- Regular review of CRO filing status preferably by direct access to CRO TMF system or by receiving reports from CRO TMF Manager.
- Performs quality control of CRO TMF regularly during conduct of study and prior final transfer.
- Manages TMF transfer from CRO and study documents archiving in eTMF according to the study specific TMF plan and internal quality documents. Verifies that key documents for non-clinical and Project Master Files for SWITCH studies are filed in eTMF system. Ensures quality check of the documents received is performed.
Serving as Veeva CTMS & eTMF system expert for Clinical Evidence team and other functional areas:
- Being first point of contact for all team members in case of questions & issues and provide support.
- Support team members by defining ways of working and preparing appropriate documentation and training material.
- Ensures high quality data in Veeva system by regular quality check and collaboration with appropriate stakeholders.
Manages migration of clinical data and documents to new standalone platforms and systems with Digital Team;
- Contributes as business representative in the assigned projects.
- Prepares detailed list of studies for which data and documents are to be migrated.
Maintains knowledge of current regulations and IT system technology related to the data management and eTMF management function.
About you:
Experience: 7-10 Years of experience
Why us?
At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.
We Are Challengers.
We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:
All In Together: We keep each other honest and have each other's backs.
Courageous: We break boundaries and take thoughtful risks with creativity.
Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.
Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.
Join us on our mission. Health. In your hands.