At Capgemini Invent, we believe difference drives change. As inventive transformation consultants, we blend our strategic, creative and scientific capabilities, collaborating closely with clients to deliver cutting-edge solutions. Join us to drive transformation tailored to our client's challenges of today and tomorrow. Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose.
Your Role
The Senior Clinical Data Manager (SCDM) is responsible to perform and assist in data management activities like EDC build, coding, query management, external data reconciliation, SAE reconciliation, EDC testing and writing test scripts, data cleaning. Act as back up to Lead Clinical Data Manager. If required, lead studies independently.The Senior Clinical Programmer (SCP) plays a pivotal role in supporting clinical research by developing, validating, and maintaining statistical programs and datasets. Collaborating with Biostatisticians, Clinical Data Managers, and cross-functional teams, the Senior Clinical Programmer ensures high-quality, timely deliverables that meet regulatory standards and study objectives. This role requires advanced SAS programming expertise, strong problem-solving skills, and the ability to mentor junior team members.
In this role you will play a key role in:
As an SCDM
- The SCDM should thoroughly understand the requirements for Good Clinical Data Management services, including its documentation; be willing to be involved in start-up or wrap-up of in-house and client-specific data management projects; have an understanding of the relevant therapeutic indications, study hypotheses, and trial design; and have a solid understanding of database design and structure.
- Support LDM in managing the work of outsourcing vendors and support LDM in approving the following key standard study documents: CCGs, Raw Data Validation Checks, User Acceptance Testing documents, eCRF development and DB lock plans. Approve the key documents in the absence of LDM.
As an SCP
- The SCP should thoroughly understand the requirements for Good Clinical Data Management services, including its documentation; be willing to be involved in start-up or wrap-up of in-house and client-specific data management projects; have an understanding of the relevant therapeutic indications, study hypotheses, and trial design; and have a solid understanding of database design and structure.
- Program customized data displays, (including data listings, summary tables and routine graphics) in accordance with the approved statistical analysis plan (SAP) and shell displays for clinical research studies. Analyze protocol, SAP, existing shells/templates as needed to understand structure and content of data. Create SAS datasets of clinical data from clinical databases, status and efficacy datasets, project-specific macros and formats & study reports using SAS or Program R.
Your Profile
- Perform and assist in data management activities like data validation, discrepancy review, query resolution, and reconciliation & Act as back up to Lead Clinical Data Manager. If required, lead studies independently. Support LCDM or independently prepare all study specific procedures (DMP, CCG etc).
- Create Data transfer agreements when required. Take part in study kick off (internal and external) meetings. Review Case Report Forms (CRFs) and Edit checks specifications. Ensure all deliverables meet quality standards and customer expectations.
- Lead or support LCDM and coordinate other team members, providing guidance and support. Communicate with sponsors, sites, and other departments to facilitate data collection and resolve issues if required in the absence of LCDM.
- Assist LCDM in tracking and managing projects, identifying risks, and taking corrective actions. Perform User Acceptance Testing (UAT). Provide regular study status updates to the LCDM & Support the LCDM in the delivery of study specific training to all team members, ensuring that the training is documented and the documentation filed in the TMF.
What You Will Love About Working Here
- We recognize the significance of flexible work arrangements to provide support. Be it remote work, or flexible work hours, you will get an environment to maintain healthy work life balance.
- At the heart of our mission is your career growth. Our array of career growth programs and diverse professions are crafted to support you in exploring a world of opportunities.
- Equip yourself with valuable certifications in the latest technologies such as Generative AI.
Capgemini is a global business and technology transformation partner, helping organizations to accelerate their dual transition to a digital and sustainable world, while creating tangible impact for enterprises and society. It is a responsible and diverse group of 340,000 team members in more than 50 countries. With its strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. It delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.
