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Senior Clinical Project Manager (Cosmetics)

Want to see your scientific expertise go further? As Senior Clinical Project Manager (Cosmetics) at Reckitt, you’ll have the freedom to develop healthcare products that impact millions of lives. Worldwide. 

 

Senior Clinical Project Manager (Cosmetics)

Slough, Berkshire

Competitive Salary & excellent benefits package

 

This is a senior role within the Clinical Operations team to meet business objectives through insight into Reckitt products from available data, sound oversight of clinical study activities and the generation of robust clinical study evidence.

 

Role Purpose:

  • To optimise the generation and delivery of robust evidence to meet business objectives.  Partnering effectively with Reckitt cross functional Teams and clinical vendors, the role provides health outcomes and consumer-centric strategic input into projects and contributes to business objectives being translated into study endpoints and claims
  • To deliver and coach best practices in clinical study conduct
  • To deliver clinical studies to meet business objectives in accordance with SOPs, ISO standards and Regulatory requirements. 

 

Scope: 

  • This role is part of the Evidence Generation and Clinical Research team and reports to the Senior Manager Clinical Operations. The role focuses on clinical study conduct and delivering clinical study operational excellence to provide all Reckitt Health Hygiene and Reckitt Health innovation projects that require clinical and/or health outcomes evidence to support desired claims and messages
  • The role provides clinical input into Health Hygiene and Reckitt Health clinical studies and initiatives (US, EU and any other territory in which Reckitt operates) through an understanding of clinical study and regulatory requirements and clinical oversight
  • The role contributes at a departmental level to ensure Clinical Operations as part of the Medical Affairs and Evidence Generation team is at the forefront of process excellence to meet wider business goals and objectives.

 

Insight

  • Utilise clinical study data from previous studies for strategic use
  • 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 endpoints) on more complex clinical topics
  • Gain strategic awareness about projects related to assigned clinical studies
  • Critically read and evaluate relevant literature on clinical methodologies, health outcomes, study designs and results from existing literature and communicate content to project teams.

As a clinical representative you will: 

  • Lead the study teams for assigned clinical studies in a matrix structure building effective relationships with study teams, ensuring agreed timelines are met
  • Attend the Scientific Review Committee meetings and high-level strategy meetings for the assigned clinical studies
  • Contribute to the evaluation of probability of success and potential risks when clinical studies are being planned against business objectives
  • Build effective relationships across Medical Affairs and Evidence Generation and the wider Reckitt Business to set up, execute and deliver appropriate clinical studies
  • In partnership with Biometrics and Outcomes, Medical Science and Regulatory Affairs, provide input to project feasibility assessments and subsequent project strategy documents
    • Identify opportunities to make projects bigger by integrating health outcomes and consumer-centric approaches at an early stage
    • In collaboration with the Outsourcing Manager, contribute planning, resource, and project information into the portfolio management system
  • Facilitate the development of Evidence Briefs for assigned projects by leveraging best-practise collaboration (involving the right people at the right time) to ensure scientifically robust evidence generation activities are integrated to the project
  • Represent Reckitt in the external environment, e.g. working with KOLs, Regulators etc. as required, optimising project development strategies.

 

Day-to-day activities:

  • Manage and oversee Cosmetic clinical studies of low to high complexity
  • Lead a suite of clinical studies (program)
  • 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 the external vendor staff are sufficiently trained and experienced to conduct each specific clinical activity
  • Ensure study designs and endpoints for planned clinical studies are in line with the required standards for cosmetic clinical testing (i.e. Principles of GCP, ISO, any local regulatory standards) and are optimal for meeting the study objectives
  • Author or review Protocols
  • Author or review various other study related documentation
  • Author or review Clinical Study Reports
  • Manage and adhere to agreed timelines for studies
  • Manage applicable (vendor) contracts
  • Manage payments to vendors and manage study budgets
  • Provide regular status reports to Senior Management
  • Assist in filing essential study documents and correspondence in the TMF
  • Assist with TMF archiving
  • Support the development of slide sets, reports and publications (abstracts, posters, manuscripts) for internal and external communication of study results.

People Management:

  • May perform line management tasks for direct reports assigned including targeted personal and technical development and training
  • Support and coach the Clinical Study Managers to generate study protocols that incorporate all elements of the Evidence brief so that the protocols are aligned with the project evidence requirements to incorporate clinical endpoints, comparators, healthcare use, and Patient Reported Outcome (PRO) endpoints
  • Assist in keeping the team updated on new clinical and evaluate whether they should be used in Reckitt studies
  • Where applicable manage overall resource and study allocation
  • Assist in managing departmental budget for direct reports
  • Assist in producing and tracking clinical performance metrics
  • In case of direct reports, ensure the team are sufficiently trained and experienced to conduct each specific clinical activity
  • Collaborate with other regions and actively participate in the globalisation of the team.

Key Challenges:

  • Understanding of the entire process of clinical development and execution and how this interfaces and drives the organisation
  • Ability to work with and influence multiple stakeholders in a matrix organisation
  • Meeting pre-agreed timelines
  • Managing conflicting priorities between clinical study activities with evolving and often challenging timelines
  • Creating and maintaining good working relationships with external vendors.

 

Skills & Experience Required:  

  • At least 3-4 years (Master’s degree) or 4-5 years (Bachelor’s degree) of clinical development experience preferably in a clinical department in the consumer healthcare/cosmetic industry or at a CRO or clinical vendor
  • In depth and up to date knowledge of GCP and regulatory standards
  • Strong project management and organisational skills
  • Computer literacy (Advanced Microsoft Skills)
  • Line Management experience is preferable
  • Experience with skin measurement science techniques and knowledge of clinical antimicrobial testing standards is preferable
  • Experience or interest in skin and microbiome science and staying abreast with the latest emerging sciences and innovations is desired.

 

Technical/professional qualifications required:

  • Bachelor’s or Master’s degree in science or a bioloy-related field with an advanced degree and/or certification preferred.

 

Personal Attributes:  

  • Excellent communication skills, both written and oral
  • Pro-active and self-directed with a high level of initiative and persistence
  • Detail orientated
  • Ability to manage teams from a line management perspective and in a matrix structure
  • Ability to manage priorities.
  • Ability to influence without authority
  • Good interpersonal skills, ability to operate successfully in various team capacities and in a multi-cultural environment
  • Strong analytical skills with the ability to implement plans, recognise patterns and develop innovative solutions
  • Ability to develop and succinctly communicate strong argumentation to influence.

Equality

In return Reckitt offer very competitive salaries with excellent benefits and the chance to progress your career within a truly global organisation.
Reclitt is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other basis protected by appropriate law. All hiring decisions are made based on merit, competence and business need.


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