Managing Consultant/ Senior Manager - End-to-End Clinical Data Flow
Informed and validated by science and data. Superpowered by creativity and design. All underpinned by technology created with purpose.
YOUR ROLE- Our team is growing, and we require further E2E clinical data flow domain experience and expertise.
- We are delivering impactful programmes focusing of transforming clinical trial data flows, the associated business processes, and the organisation. Some of these engagements are End-to-End transformation programmes, while others focus on study design, protocol design, data management or submissions as an example.
- We will value your consulting and sector expertise to help clients reach their business objectives and accelerate delivery of life saving medicines to patients.
- Life Sciences are a high growth sector within a fast-growing business, our aim is to treble our revenues in the sector over the next 2 years.
As a Senior Manager in the business, you’ll help set the direction, driving forward the business, model our values and behaviours, and coach and develop junior members of the team. Key expectations from this role include:
- Lead and manage end-to-end implementation projects of Clinical Solutions for clinical research /Biopharma /MedTech organizations, from planning and execution to monitoring and delivery, ensuring adherence to timelines, budgets, and quality standards.
- Collaborate with external stakeholders, including Clinical Operations and/or Clinical Data Management, to gather requirements and define project scopes for technology implementation and business process reengineering initiatives.
- Develop comprehensive project plans, including resource allocation, risk assessment, and mitigation strategies, to drive successful execution.
- Coordinate with internal stakeholders and partners to facilitate the implementation of Clinical Solutions and ensure a smooth implementation process. Identify opportunities for process optimization and reengineering to enhance clinical operations, data collection, and analysis efficiency.
- Monitor project progress, identify deviations from the plan, and proactively resolve issues to keep projects on track. Ensure compliance with regulatory requirements, industry standards, and best practices in all project activities, with a strong focus on Good Clinical Practice (GCP) guidelines.
- Have a POV on how the clinical development landscape and submissions will evolve over the short, medium and long-term.
- Manage and mentor a number of colleagues, as part of the sector team and also client engagements.
- Contribute to business development ncluding writing and delivery of client pitches, innovative offers and accelerators.
As part of your role you will also have the opportunity to contribute to the business and your own personal growth, through activities that form part of the following categories:
- Business Development – Leading/contributing to proposals, RFPs, bids, proposition development, client pitch contribution, client hosting at events.
- Internal contribution – Campaign development, internal think-tanks, whitepapers, practice development (operations, recruitment, team events & activities), offering development.
- Learning & development – Training to support your career development and the skills demand within the company, certifications etc.
- Experience in leading Clinical trial transformation within large Pharma
- Strong understanding of the technology and data landscape within Clinical Development
- Demonstrated expertise in managing technology implementation projects, particularly Clinical Solutions such as Electronic Data Capture (EDC) systems, Clinical Trial Management Systems (CTMS), and related tools.
- Clear view and knowledge of clinical data standards.
- Comprehensive understanding of clinical research processes, biostatistical environment and regulatory guidelines (e.g., ICH-GCP) governing clinical trials.
- Strong leadership, communication, and interpersonal skills, with the ability to build and lead cross-functional teams effectively.
- Excellent analytical and problem-solving abilities, with a keen eye for identifying opportunities for process optimization and reengineering.
- Passion for and who has potentially explored the value that can be derived from application of AI/Gen AI.
- Previous lead role within a CRO and consulting is beneficial.
Specific experience and knowledge in the following areas is highly desirable:
- Organisational Change Management experience, covering strategy, training, communications and system adoption support, within Pharma/CRO/Clinical systems provider.
- Good understanding of clinical operations and end-to-end data flow.
- Good understanding and experience of clinical development activities ensuring high quality and on-time delivery of all clinical needs through to submission.
- Project Management Professional (PMP) certification is a plus.
- Familiarity with software development life cycle (SDLC) and Agile methodologies is an advantage.
With breadth of demonstrable experience in:
- Leading a workstream and teams within projects and large programmes.
- Clinical domain and managing complex transformations (minimum 5 years of direct experience).
- Senior client stakeholder management experience.
- Project management, team leadership and coaching.
- Business development activities with the ability to story-tell & lead winning proposals.
WHAT YOU’LL LOVE ABOUT WORKING HERE?
Life Sciences organisations (Pharma and MedTech) continue to transform alongside the emerging possibilities of technology and data. Heightened patient and consumer expectations are creating significant opportunities and challenges for established companies and emerging players.Leveraging our strong network of clients, talent and assets, we are ideally positioned to help our clients re-invent their business models, deliver transformative solutions and delight their customers. With deep understanding of the Life Sciences industry, an innovative mindset, and a highly collaborative working style, you will help to shape our consulting capability by driving new growth and expanding existing business.
We are delighted to have received the “Glassdoor Best Places to work UK’ accolade for 4 consecutive years, to see what it’s like to work at Capgemini Invent, visit our Glassdoor page
NEED TO KNOW
At Capgemini we don’t just believe in Diversity & Inclusion, we actively go out to making it a working reality. Driven by our core values and Active Inclusion Campaign, we build environments where you can bring you whole self to work.
We aim to build an environment where employees can enjoy a positive work-life balance. We embed hybrid working in all that we do and make flexible working arrangements the day-to-day reality for our people. All UK employees are eligible to request flexible working arrangements.
Employee wellbeing is vitally important to us as an organisation. We see a healthy and happy workforce a critical component for us to achieve our organisational ambitions. To help support wellbeing we have trained ‘Mental Health Champions’ across each of our business areas.We have also invested in wellbeing apps such as Thrive and Peppy.
CSR:
We’re also focused on using tech to have a positive social impact. So, we’re working to reduce our own carbon footprint and improve everyone’s access to a digital world. It’s something we’re really serious about. In fact, we were even named as one of the world’s most ethical companies by the Ethisphere Institute for the 10th year.When you join Capgemini, you’ll join a team that does the right thing.
Whilst you will have London, Manchester or Glasgow as an office base location, you must be fully flexible in terms of assignment location, as these roles may involve periods of time away from home at short notice.
We offer a remuneration package which includes flexible benefits options for you to choose to suit your own personal circumstances and a variable element dependent grade and on company and personal performance.
ABOUT CAPGEMINI
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, cloud and data, combined with its deep industry expertise and partner ecosystem.
The Group reported 2023 global revenues of €22.5 billion.