At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at https://www.jnj.com
Job Function
R&D Operations
Job Sub Function
Clinical Trial Project Management
Job Category
Professional
All Job Posting Locations:
High Wycombe, Buckinghamshire, United Kingdom
Job Description
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine.
Johnson and Johnson is currently seeking a Manager, Feasibility. The position can be located in the US (Titusville, NJ; Spring House, PA) or EMEA (Beerse, Belgium; Basel, Switzerland; High Wycombe, United Kingdom).
The Manager, Feasibility, is responsible for the development and performance measurement of the trial level feasibility plan. The Manager, Feasibility will lead the alignment, commitment(baselining), and rebaselining processes for their assigned programs or studies and will present key insights and
recommendations to stakeholders.
Principal Responsibilities
* Responsible for the development of study-level Feasibility strategy and the management of trial-level execution against the plan.
* Support deployment of DAS or program level feasibility strategies and incorporate them into study-level strategies and plans.
* Lead process of aligning trial baseline commitments for site activation and recruitment expectations, facilitate the study scenario planning, probability forecasting and re-baselining (as needed) process (country and study levels), and document changes from Early Estimates, Early Feasibility, Detailed Assumptions, Detailed Feasibility, to Start-Up Planning and Recruitment.
* Ensure country POCs have relevant TA clinical development plan information and provide strategic direction to facilitate local feasibility completion. Identify regional or country disparities based on insights on feasibility from data analytics team and countries (incl. past performance data and proposed scenarios) and resolve these with country POC.
* Present overall feasibility insights summary, key questions, recommendations, and updates on feasibility process to study team stakeholders within set timelines.
* Work closely with PSE managers and local teams to create an implementation plan that integrates PSE knowledge on site engagement and DEICT requirements into feasibility analyses.
Additional Responsibilities May Include
* Mentor & support onboarding of new team members, particularly those in Trial Management.
* Foster employee engagement, inclusion, and Credo Behaviors.
Principal Relationships
* Internal: DAS Leaders, Clinical Delivery Leaders, Clinical Trial Leaders, Clinical Trial Managers, Site Managers, Local Trial Manager, Country Heads, Clinical Team representatives, Data Science representatives
* External: Investigational sites, Key Opinion Leaders, Patient Engagement Groups, Vendors with a focus on study placement or recruiting and retention capabilities
Qualifications
* Required minimum education: BS degree, preferred areas of study include Life Sciences (Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy)
* Required Years of Related Experience: Minimum of 8 years in Pharmaceutical, Healthcare or related industries.
* Required Knowledge, Skills and Abilities: Requires clinical research operational knowledge and experience across multiple phases of studies (Phase I-IV); knowledge of GCP and a good understanding of the processes associated with study / site feasibility, study/project management, monitoring, clinical and regulatory operations.
* Broad-based experience in data analytics / evaluation; ability to leverage, interpret, represent, and drive unbiased data insight into clinical trial operational planning.
* Advanced skills to develop deep insights, uncover unmet needs, drive innovation, inspire, develop, collaborate, and lead within a global matrixed team.
* Exceptional interpersonal skills, including ability to persuade, negotiate, and moderate conflict. Strong presentation and communication skills.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
* Titusville, NJ and Springhouse, PA- Requisition #: R-009725
* Beerse -Requisition #: R-010250
* High Wycombe -Requisition #: R-010252
* Basel -Requisition #: R-010256
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource. #J-18808-Ljbffr