Clinical Data Manager

BAT is evolving at pace - truly like no other organisation.

To achieve the ambition, we have set for ourselves, we are looking for colleagues who are ready to live our ethos every day. Come be a part of this journey!

SENIORITY LEVEL: Junior Level

FUNCTION: Scientific Research & Development

SUB FUNCTION: Global Life Science, Global Clinical Studies Division

LOCATION: Southampton, UK

TYPE OF CONTRACT: Permanent

BENEFITS

• UK yearly Incentive Bonus – driven % based on business results and average annual salary
• Attractive Private Pension Plan - up to 15%, Private Medical cover, Doctor @hand-24/7 GP appointments, by video or by phone, 365 days a year, from anywhere in the world
• Share Reward Scheme (free shares and share saving scheme), Group Personal Accident Insurance, Life Assurance
• Flexible Benefits Scheme: Tax Return Assistance, Cycle To Work, Holiday Trading, Dental Insurance, Travel Insurance; Onsite Gym and Gyms Discounts-discounts at over 3,700 gyms, SPAs, pools, studios and outdoor fitness events across the UK; Season Ticket loans-Interest free loans for purchase of annual tickets for public transport

What are the key objectives and expectations from this role?  

The Clinical Data Manager will collaborate with the Clinical Studies team, other members of Global Life Science, Product Development teams, and senior management across the enterprise regarding the project management of the data management deliverables of clinical studies and deliver on timelines. Co-Lead, manage and/or execute multiple clinical data management deliverables simultaneously.  Actively partner across functional areas within the enterprise and with external vendors to ensure data management deliverables and timelines are met.

What is the direct impact of this role on the team or organization?

This role is part of the Global Life Science’s Clinical and Behavioral Sciences sub-function. The role of Global Life Science is to lead and drive the science program for BAT and to provide scientific evidence for BAT’s products in support of tobacco harm reduction initiatives and regulatory priorities. The Clinical Studies team supports the Global Life Science objectives by leading and overseeing the design, initiation, execution, and reporting of global clinical studies.

WHAT YOU WILL BE ACCOUNTABLE FOR

• Function as a Clinical Data Manager (CDM) to coordinate the day-to-day support of CDM deliverables from study start-up through to database lock to receipt of final study outputs for clinical studies outsourced to contract research organizations.
• Work collaboratively with project study teams comprised of internal staff and external vendors for multiple global projects assigned to the post holder.  Handle timelines of CDM deliverables for assigned projects, ensuring the internal project team is up to date on these activities.
• Ensure that clinical or other relevant human research studies are designed and conducted in compliance with Good Clinical Practices (GCP) requirements, applicable regulations/guidance, global/internal data standards (CDISC) and company Standard Operating Procedures. 
• Contribute to or assist in development of request for proposal (RFP) for CDM needs, where needed including Electronic Data Capture (EDC) platforms, budget implications, overall governance of CDM processes and outsourcing.
• Provide expertise in design and delivery of internal eCRF specifications according to protocol and approved standards for assigned clinical studies; oversee development of new standards as needs permit.
• The CDM role will take direction from the clinical operational unit, including undertaking any other tasks allocated to them within the CDM domain following discussion. 

CAN THIS BE YOUR FUTURE ROLE?

• Do you have previous experience of Clinical Data Management?
• Are you aware of ICH GCP and its meaning?
• Do you have experience of managing external vendors?

ESSENTIAL EXPERIENCE, SKILLS, AND KNOWLEDGE

Experience Required

• Previous direct experience of data management activities in clinical studies and proficient level of understanding clinical research processes and clinical data management lifecycle.

Technical / Functional / Leadership Skills Required

• Ability to drive cross-functional collaborative efforts with multiple collaborators, internal clinical research partners and outsourced vendors.
• Capacity to work and make decisions with minimal supervision.
• Excellent time management and team collaboration skills.
• Excellent oral and written communication skills.
• Aptitude and ability to apply and document quality and regulatory practices / procedures supporting research studies.
• Ability to creatively contribute to key strategies at the department/division/enterprise level.

Education / Qualifications / Certifications Required

• PhD, Master’s, or bachelor’s degree required in a scientific field.

BENEFICIAL

• Experience with regulatory submissions

WE ARE BAT

At BAT we are committed to our Purpose of creating A Better Tomorrow. This is what drives our people and our passion for innovation. See what is possible for you at BAT.

• Global Top Employer with 53,000 BAT people across more than 180 markets
• Brands sold in over 200 markets, made in 44 factories in 42 countries
• Newly established Tech Hubs building world-class capabilities for innovation in 4 strategic locations
• Diversity leader in the Financial Times and International Women’s Day Best Practice winner
• Seal Award winner – one of 50 most sustainable companies

BELONGING, ACHIEVING, TOGETHER

Collaboration, diversity and teamwork underpin everything we do here at BAT. We know that collaborating with colleagues from different backgrounds is what makes us stronger and best prepared to meet our business goals. Come bring your difference!