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R&D Associate, Clinical Project Management

Reports to:

Senior Manager, Clinical Operations/Senior Clinical Study Manager

Role Purpose:

•    To optimise the generation and delivery of robust evidence to meet business objectives. Partnering effectively with RB 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 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 a Senior Manager, Clinical Operations or Senior Clinical Study Manager. The role focuses on clinical study conduct and delivering clinical study operational excellence to support all RB Health Hygiene and RB Health innovation projects that require clinical and/or health outcomes evidence for the generation of desired claims and messages. 
•    The role provides clinical input into Health Hygiene and RB Health clinical studies and initiatives (US, EU and any other territory in which RB operates) through an understanding of clinical study and regulatory requirements and clinical oversight.

Accountabilities:

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

INSIGHT

 

•    Utilise clinical study data from previous studies for strategic use.
•    Give valid interpretations and any limitations from past data.
•    Assist in giving 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.

EVIDENCE

 

Act as a clinical representative: 
•    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 into 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 RB Business to set up, execute and deliver appropriate clinical studies. Assist in representing RB in the external environment, e.g. working with KOLs, Regulators etc. as required, optimising project development strategies.

Perform day-to-day activities:

•    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 RB requirements.
•    Ensure the external vendor staff are sufficiently trained and experienced to conduct each specific clinical activity.
•    Manage and oversee clinical studies (IMP, device, cosmetics) of low to normal complexity/single country.
•    Assist in managing and overseeing clinical studies of high complexity/multiple regions.
•    Ensure study designs and endpoints for planned clinical studies are in line with the required standards (i.e. ICH-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.
•    Assist in providing 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.

OVERSIGHT

 

Compliance and adherence to SOPs:
•    Ensure that clinical activities are performed to the required standards (i.e. ICH-GCP, ISO, any local regulatory standards) and ready for inspection.
•    Input into and adhere to the clinical standard operating procedures.

Governance of vendors:
•    In collaboration with Outsourcing Manager: 
    o    Optimise outsourcing of health outcomes activities considering costs, quality and time constraints. 
    o    Evaluate performance of vendors. 
    o    Attend governance meetings with vendors as required. 

Key Challenges:

•    To understand the entire process of clinical study management and execution and how this interfaces and drives the organisation. 
•    Able to work with and influence multiple stakeholders in a matrix organisation.
•    Able to set and meet project timelines.
•    Manage conflicting priorities between clinical study activities with evolving and often challenging timelines.
•    Create and maintain good working relationships with external vendors.

Skills & Experience Required:

•    At least 2-3 years (Master’s degree) or 3-4 years (Bachelor’s degree) of clinical operations experience preferably in a clinical or medical department in pharmaceutical/consumer healthcare/cosmetic industry or at a CRO or clinical vendor.
•    In depth and up to date knowledge of GCP/regulatory standards.
•    Strong understanding of corporate and operational business needs.
•    Project management and organisational skills.
•    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. 

Personal Attributes:

•    Pro-active and self-directed with a high level of initiative and persistence.
•    Detail orientated.
•    Ability to manage clinical studies and priorities. 
•    Ability to influence without authority.
•    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.

People responsibility:

•    No Direct Reports 

Equality

In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly global organisation.
RB 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.


Nearest Major Market: New York City
Nearest Secondary Market: Newark

Job Segment: Clinic, Medical, Medical Research, Clinical Research, Healthcare

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