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R&D Sr. Associate, Clinical Project Management

Reports to:

(Senior) Manager Clinical Operations 

Role Purpose:

•    To optimise the generation and delivery of robust evidence to meet business objectives.  Partnering effectively with RB crossfunctional 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 Manager Clinical Operations. The role focuses on clinical study conduct and delivering clinical study operational excellence to provide all RB Health Hygiene and RB 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 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.
•    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.

Accountabilities:

This is a senior 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.
•    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

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 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 RB 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.
    o    Identify opportunities to make projects bigger by integrating health outcomes and consumer-centric approaches at an early stage
    o    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 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 high complexity in a single country or across multiple regions.
•    Lead a suite of clinical studies (program).
•    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.
•    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.

Managing people:

•    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 RB 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.

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 standard operating procedures.
•    Ensure best practices and consistency within the team.

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:

•    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 or medical department in a 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.
•    Strong project management and organisational skills.
•    Computer literacy (Advanced Microsoft Skills).
•    Line Management experience preferable.

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:

•    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.

People responsibility:

•    May have up to 5 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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