Clinical Research Manager - Johnson & Johnson

The Clinical Research Manager will be responsible for providing scientific, technical and operational expertise in the planning, implementation and closeout of all GPH evidence generation activities across all relevant Therapeutic Areas and geographies.

The responsibilities & the impact YOU will have:

Key Responsibilities are:

Study Design, Protocol Development & Data Collection

• Provide scientific, technical and operational expertise in the planning, execution and closing out of all GPH evidence generation activities including Company Sponsored Studies (CSS), Investigator-Initiated Studies (IIS) & Collaborative Studies.
• Work closely with key internal stakeholders such as Global Medical Affairs Leaders of priority Therapeutic Areas, Global Trial Leaders, Market Access Teams etc during IEGP cycles to identify evidence gaps and design research solutions to fill those gaps.
• Drive the development of protocol elements documents for research concepts, review and approval of these concepts through the designated approval systems such as recap, Clinical Teams, Global Review Committees

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• Lead protocol development post concept approval (outlining purpose and methodology).
• Present trial protocols to review committees as required.
• Contribute to the design of data collection tools such as case report forms (CRFs) as needed.
• Drive protocol submissions to the ethics committee and regulatory authorities depending on study type.
• Identify and assess the suitability of facilities to use as the clinical trial sites.
• Review, identify and select the right investigators for all trials.
• Coordinate closely with all parties involved in the set-up and implementation of trials including CROs.
• Drive site training in close collaboration with study sponsors.
• Select the most appropriate CRO to lead trial monitoring, data collection amongst other activities.
• Develop the task list for each study and assign responsibilities based on study type monitor the trial throughout its duration, which involves visiting the trial sites on a regular basis.
• Drive close down of trial sites on completion of the trial.
• Planning, implementation and closeout of post-trial access programs.

Publication

• Contribute to, and drive the development of clinical study reports and manuscripts for publication based on study type.
• Contribute to, and drive the development of a global publication plan, including posthoc analyses of current datasets for publication. Where required, coordinate the contracting of and external parties’ stakeholders and oversee the delivery of services.
• Drive execution of, and track progress against the publication plan milestones and disseminate progress reports as required.
• Contribute to the development of publications, materials and processes to improve internal and external product knowledge. Work closely with line manager to maintain and manage communications with experts and authors and contribute to scientific discussions related to trial design and study results for publication purposes.
• Maintain oversight and act as a point of contact for all study publications in line with relevant Company SOPs, including IIS.
• Support regional Medical Affairs activities involving product evaluation, labelling and surveillance, as well as identify new opportunities in collaboration with marketing and new business development.
• Share scientific knowledge and provide input into core documents and respond to program-related questions.

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Qualifications

We’d love to hear from YOU if you have:

Required:

• Education: A degree in medicine, or a degree or postgraduate qualification in life sciences.
• Years of Experience 8 up to 10 years of relevant experience;
• Language: Fluent English.

Technical Skills: 

• Excellent knowledge of study design & execution and related regulations (GCP, European Directives, Helsinki).
• Good working knowledge of publication management, benefit/ risk management, real-world data, and access programs.
• Medical writing skills.
• Clinical research strategy development.
• Stakeholder mapping and engagement.
• Ability to work with a diverse group of people in a matrix organization.
• Strong and demonstrable communication and influencing skills that can impact at a global and regional level.

Leadership Skills:

• Leadership, people management and development skills.
• Highly innovative with the ability to drive multiple projects within a complex and changing environment, and effectively manage and resolve issues within program management teams.
• Excellent interpersonal and interdependent partnering skills.
• Ability to drive change to influence and through impactful partnerships.

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