Primary Function of Position: The Future Forward Global Clinical Research Manager will be a pivotal leader in helping shape the clinical strategy and guiding the design of clinical studies and building strategic clinical evidence to drive product innovation and development.
This role focuses on leveraging clinical data and insights to inform product design and development ensuring that new medical technologies are optimized for patient outcomes and regulatory success.
The ideal candidate has deep expertise in translating clinical research insights into strategic product decisions and a strong background in developing clinical protocols for novel technologies.
Roles and Responsibilities: Clinical Trial Design Development and Management : Crossfunctional collaboration with key internal and external stakeholders to design and develop clinical protocols and execute clinical studies (premarket or postmarket studies) with minimal supervision.
Oversight study conduct and including data management including direction and support for clinical research organizations (CROs) clinical research associates (CRAs) clinical trial assistants (CTAs).
Oversight and development of all study materials including but not limited to protocols informed consent data collection forms and study binders for all Company sponsored trials maintaining all global GCP requirements.
Responsible drive the progress of the trial during site selection site startup and through enrolment and followup.
Partnership and guidance to the study monitors about monitoring needs and oversee compliance work on the study.
Manage Future Forward clinical research activities including planning site selection patient recruitment and document creation (protocols case report forms informed consents clinical trial agreements study reports).
Ensure Future Forward clinical studies are conducted on schedule within budget and in compliance with quality standards.
Provide input to Product Development based on patient risks and clinical data.
Serve as a liaison with research sites to ensure study compliance and progress.
Collaborate with internal stakeholders investigators and KOLs to develop and review study designs protocols and initiatives.
Perform site qualification initiation visits and audits ensuring sponsor readiness.
Negotiate contracts and budgets with vendors and sites in partnership with legal and management.
Track study progress provide status reports and manage site payments and financial tracking tools.
Support study startup approvals and site monitoring.
Work with biostatisticians on data analysis clinical study reports and scientific publications.
Organize study meetings and mentor junior team members.
Ensure compliance with corporate SOPs GCP and regulatory guidelines.
Evidence Generation Build and maintain positive relationships with key opinion leaders medical advisors and clinical leaders.
Collaborate with crossfunctional teams to understand market trends and align clinical activities with Future Forward business goals.
Assist in preparing manuscripts abstracts and presentations for scientific meetings and publications.
Collaboration on evidence generation strategies and.
Post Market Surveillance Support postmarket research and regulatory submissions addressing regulatory questions and ensuring clinical study compliance.
Contribute to regulatory processes related to adverse events product complaints risk assessments and recalls.
Qualifications : Required Knowledge Skills and Experience: Minimum bachelors degree in a life science health sciences nursing or related field Minimum of 510 years of experience in clinical research is preferred.
Proven track record in the development and of global clinical research and evidence generation.
Experience and successful track record with innovative medical technologies and novel interventions.
Required Skills and Experience: Previous experience implementing helping and managing medical device trials preferably for innovative or emerging technologies.
Proven experience in protocol and ICF development writing clinical section(s) for regulatory submission.
Proven experience in conducting literature searches reviews and appraisal of the scientific data.
Excellent ability to interact with physicians and other professionals inside and outside the company.
Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations fundamental knowledge of clinical research and monitoring requirements.
Experience negotiating clinical research contracts and budgets.
Must be able to work effectively on crossfunctional teams.
Must be able to travel 2540 or based on business requirements.
Must be able to manage multiple projects and/or manage different priorities.
Proven communication presentation and relational skills with high attention to detail and organization.
Ability to learn quickly tailor to shifting requirements and selfeducate on different surgical specialties as applicable to clinical projects (selfstarter attitude).
Ability to manage and motivate project teams consisting of CRAs and CTAs and support management with relevant study updates.
Exhibits solid work ethic to help meet tight timelines or multiple projects when necessary with a problemsolving mindset.
Preferred Skills and Experience : Accustomed to working in a hospital environment experience working with nurses and surgeons preferred.
Working knowledge or experience with global regulations related to clinical studies and submissions to regulatory authorities.
Experience presenting and providing clinical education on medical technology to both medical and nonmedical personnel.
Broad knowledge in surgical and endoscopic procedures.
Evidence of work style characterized by vision teamwork preparation communication and negotiation.
A history of successfully managing relationships at all levels of the organization.
Resultsoriented individual skilled in motivating and inspiring people.
Good oral and written communication skills for both scientific and nonscientific groups.
Effective analytical and problemsolving skills with the ability to manage multiple projects and apply creative solutions to challenges.
Commitment to patient safety and professional ethics as top priority Additional Information : Intuitive is an Equal Employment Opportunity Employer.
We provide equal employment opportunities to all qualified applicants and employees and prohibit discrimination and harassment of any type without regard to race sex pregnancy sexual orientation gender identity national origin color age religion protected veteran or disability status genetic information or any other status protected under federal state or local applicable laws.
We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.
Remote Work : No Employment Type : Fulltime Key Skills CSS, Cloud Computing, Health Education, Actuary, Building Electrician Experience: years Vacancy: 1
Future Forward Global Clinical Research Manager, Berkshire
Free
Future Forward Global Clinical Research Manager, Berkshire
United Kingdom, Berkshire, Berkshire,
Modified April 10, 2025
Description
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