Clinical Operations Manager

We are Reckitt

​Research & Development​

About the role

As a Clinical Operations Manager you will support the Clinical Operations Senior Manager in leading the Evidence Generation and Clinical Research (EGCR) team to deliver robust clinical study data to meet the business objectives. The Clinical Operations Manager is responsible for delivering and coaching best practices in clinical study conduct. 

Your responsibilities

- Deliver key evidence supporting product claims and registration.
- Manage, support and motivate the Clinical Study Managers in the delivery of clinical investigations. 
- Ensure access to clinical study data from previous investigations.
- Research, identify and summarize outsourcing opportunities to support the business objectives.
- Give valid interpretations and any limitations from past data.
- Give expert operational advice (e.g. innovative approaches such as methods, models and techniques to achieve claims and end points) on more complex clinical topics.
- Maintain strategic awareness in order to challenge and present any arguments on behalf of the clinical team to major stakeholders.
- Gain strategic awareness about projects related to assigned clinical investigations. 
- Attend the Scientific Review Committee meetings 
- Highlight any potential risks when clinical investigations are being planned against business objectives.
- Build effective relationships with R&D, Medical Science, Safety, AE Management Regulatory, Marketing and third parties.
- Provide operational input to the project evidence plan ensuring scientifically robust evidence generation activities are integrated into the project. 
- Ensure appropriate assessment, selection and management of vendors and investigations sites, where applicable, for outsourced activities
- Contribute to contract negotiations with vendors/investigation sites.
- Ensure the clinical elements of vendor/investigation site standard operating procedures are in place and meet local, global and Reckitt requirements.
- Ensure study designs and endpoints for planned clinical investigations are in line with the required standards (e.g. ISO 14155:2020, and any local regulatory standards) and are optimal for meeting the study objectives.
- Author or review Clinical Investigation Plans, Clinical Investigation Reports and other study related documentation.
- Provide regular status reports to Senior Management.
- Perform line management tasks for direct reports assigned including targeted personal and technical development and training.
- Produce and track clinical performance metrics.
- Input into and adhere to the clinical standard operating procedures.
- Input into the development of new procedures to meet the changing requirements of the business and regulatory environment. 
- Ensure the clinical standard operating procedures are regularly reviewed, implemented and adhered to.
- Ensure that clinical activities are performed to the required standards (e.g. ISO 14155:2020, any local regulatory standards) and ready for inspection.
- Support the Clinical Study Managers and Quality GCP in the conduct and response to audits
- Ensure best practices and consistency within the team.
- Optimise outsourcing of clinical activities 
- Evaluate performance of vendors/investigations
- Attend governance meetings with (preferred) vendors across investigations.
- Creating and maintaining good working relationships with external vendors and investigation sites.
- Managing conflicting priorities across projects and between clinical study activities with evolving and often challenging timelines.
- Risk based approach to the delegation of responsibilities within the team and outsourcing to external vendors/investigation sites, maintaining accountability for oversight. 
- Effective time-management to achieve optimal balance between gaining insight, generating high value evidence, maintaining oversight and developing the team.

The experience we're looking for

- Bachelor’s or Master’s degree in science or a biology-related field
- Preferably PhD or Masters
- Significant experience in the design and execution of medical device clinical investigations preferably in a medical device/consumer healthcare company or at a CRO or clinical vendor.
- Experience of outsourcing and vendor/investigation site management. 
- Strong understanding of corporate and operational business needs.
- Line management experience. 
- In depth and up to date knowledge of ISO 14155:2020 and applicable regulatory standards e.g., Regulation (EU) 2017/745
- Effective project and program management skills.
- Profound user knowledge of all standard IS applications (MS-Office etc).
- Experience in Pharmacovigilance.
- Experience with other types of products like Medical devices, Personal care products.
- Pro-active and self-directed with a high level of initiative and persistence.
- Detail orientated.
- People management skills, being able to coach, develop and motivate direct and indirect reports to contribute at the highest performance level. 
- Good interpersonal skills, ability to operate successfully in various team capacities and in a multi-cultural environment.
- A clear and logical thinker with the ability to recognise patterns and develop innovative solutions.
- Ability to develop and succinctly communicate strong argumentation in order to influence.

The skills for success

What we offer

Equality