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Clinical Operations Program Manager - Cosmetics

Clinical Operations Program Manager - Cosmetics 
Slough, Berkshire 
Competitive Salary & excellent benefits package 

 

The purpose of this role is to assist the Senior Manager, Clinical Operations (SMCO) in leading the Evidence Generation and Clinical Research (EG&CR) team to deliver robust clinical study data to meet business objectives and to deliver and coach best practices in clinical study conduct.

 

This role is part of the EG&CR team and reports to the SMCO, Cosmetics. The role focuses on ensuring the delivery of an allocated program of cosmetic & biocide clinical studies through optimal planning, outsourcing and strategic partnerships. You will provide clinical input into Cosmetic clinical studies and initiatives (US, EU and any other territory in which Reckitt operates) through an understanding of clinical study, regulatory requirements and clinical oversight. As well as assisting the SMCO in ensuring Clinical Operations as part of the Medical Sciences team is at the forefront of process excellence to meet wider business goals and objectives.

 

This is a leadership role within the EG&CR team that supports Medical Sciences to meet business objectives in the generation of robust clinical evidence.

 

Insight:

  • Deliver key evidence supporting product claims and registration.
  • Manage, support and motivate the Clinical Study Managers in the delivery of clinical studies. 
  • Ensure access to clinical study data from previous studies.
  • 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 studies.
  • Compliance and adherence to SOPs.
  • Governance of vendors

 

Evidence

  • Attend the Scientific Review Committee meetings.
  • Highlight any potential risks when clinical studies are being planned against business objectives.
  • Build effective relationships with R&D, Medical Science, Safety, AE Management, Regulatory, Quality, Marketing and third parties.
  • Provide operational input to the project evidence plan ensuring scientifically robust evidence generation activities are integrated into the project, identifying opportunities for efficiencies and simplification across testing plan.

Day-to-day activities:

  • Ensure the delivery of an allocated program of cosmetic & biocide clinical studies within agreed timelines and budget.
  • Ensure appropriate assessment, selection and management of vendors for outsourced activities.
  • Contribute to contract negotiations with vendors.
  • Ensure the clinical elements of vendor standard operating procedures are in place and meet local, global and Reckitt requirements.
  • Ensure study designs and endpoints for planned clinical studies are in line with the required standards for cosmetic clinical testing (e.g. Principles of GCP, any local regulatory standards) and are optimal for meeting the study objectives.
  • Author or review Protocols, Clinical Study Reports and other study related documentation.
  • Provide regular status reports to Senior Management.
  • People management:
    • Perform line management tasks for direct reports assigned including targeted personal and technical development and training.
    • Produce and track clinical performance metrics.

 

Key Challenges:

  • Creating and maintaining good working relationships with external vendors.
  • 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, maintaining accountability for oversight. 
  • Effective time-management to achieve optimal balance between gaining insight, generating high value evidence, maintaining oversight and developing the team.

 

Skills & Experience Required:  

  • Significant experience (at least 5 years) in the design and execution of clinical cosmetic studies preferably in a consumer healthcare/cosmetic company or at a CRO or clinical vendor.
  • In depth and up to date knowledge of standards for cosmetic clinical testing, GCP and regulatory standards.
  • In depth experience with skin measurement methodologies and knowledge of clinical antimicrobial testing standards is preferable.
  • Strong understanding of corporate and operational business needs.
  • Effective project and program management skills.
  • Experience of outsourcing and vendor management. 
  • Line management experience is preferable. 
  • Experience or interest in skin and microbiome science and staying abreast with the latest emerging sciences and innovations is desired.
  • Computer literacy (Advanced Microsoft Skills).
  • Technical/professional qualifications required:
  • Bachelor’s or Master’s degree in science or a biology-related field with an advanced degree and/or certification preferred.

 

You’ll love it because… 
…you’ll get to make an impact like never before. The products you help us get out there will make people’s lives better. Our iconic brands will provide an incredible platform for you. And our dynamic, ownership-driven culture will help bring the very best out of you, every day. 

 

Equality

All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law. 


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