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Research Science Management III

California, CA 99999

Posted: 06/02/2023 Employment Type: Contract Department: VMS Job Number: 27417 Industry: MDEV - Medical Device

Job Description

Position Title: Research Science Management III

Position Description: Protingent Staffing has an exciting contract opportunity for Research Science Management III with our client that is fully remote.

Job Responsibilities: The purpose of this job function is to serve as a Scientific Research Program Manager (SRPM) in the Digital Business Unit to support research projects, within the United States and across the world, to demonstrate the performance and impact of Digital products and services. This role has responsibility to oversee initiation, progress, and conduct of evidence-generation studies to include those conducted by internal scientific teams as well as sponsored studies and studies done in collaboration with external research partners. The SRPM serves as a contact to all parties involved in projects, internal and external.
  • Manage and execute a portfolio of internal and external collaborative research studies and evidence-generation activities for Digital products and services, with or without the assistance of research coordinator(s)
  • Be responsible for the management of the research studies including project development, budgeting, investigator selection, analysis of potential participant recruitment, preparation of study related documents (e.g., protocols, case report forms, informed consents, research agreements), and management of Institutional Review Board and / or Ethics Committee submissions with follow through to ensure a successful outcome
  • Work with data management professionals and statisticians as needed for assigned projects
  • Maintain study documentation (e.g., correspondence, documentation required by the U.S Code of Federal Regulations (CFR), deviations, budget information)
  • Plan and manage the project timelines to ensure research studies are conducted in a timely manner and within the project budget
  • Proactively anticipate and communicate concerns, issues, and delays in the project and develops risk assessment and contingency plans
  • Prepare project status updates and power point presentations for reporting to internal and external stakeholders for assigned projects
  • Prepare reports in support of external and internal steering or advisory committees as needed
  • Manage publication development, submission, and response to peer review for related to research studies
  • Ensure compliance with corporate (e.g., SOP's) and regulatory requirements (e.g., GCP and US and international guidelines)
  • Ensure audit readiness of research projects to relevant regulatory and legal standards
  • Management of Contract Research Organization (CRO) or independent research service providers (e.g., identification of suitable partner(s), development of contracts or statements of work, and management of stakeholders to ensure project success)
  • Facilitate participation in meetings and reporting with adherence with policies
  • Review and develop internal processes (e.g., SOPs)
  • Build, nurture, and maintain relationships with external research partners and stakeholders, which may include but are not limited to surgeon key opinion leaders, operating room staff, hospital and health system administrative and technology leaders, surgical and scientific professional society leaders, and healthcare technology industry partners

Job Qualifications:
  • Bachelor’s degree or equivalent in life sciences, medicine, medical sciences, engineering, or computer/data science (required); graduate degree (preferred)
  • Experience working in the healthcare technology industry in a clinical affairs or scientific research function with evidence of full project management responsibility for at least three years (required)
  • Five years of experience in the management of research, with experience in clinical research management in both academic/hospital and industry settings (preferred)
  • Knowledge of applicable clinical research and medical device regulations and guidelines including GCP, ISO-14155, MEDDEV, MDR and Data protection rules (required)
  • Protocol and CRF development experience (required)
  • Excellent organizational skills with the ability to manage multiple projects with competing priorities (required)
  • Ability to manage a minimum of three to five research projects across different surgical disciplines and/or products (required)
  • Excellent communication and interpersonal skills with strong negotiation abilities (required)
  • Ability to work independently and across teams whilst keeping open communication with key stakeholders (required)
  • Strong numerical and literary analytical skills with the ability to assess data and literature
  • Experience reviewing data sets to evaluate data quality
  • Experience with studies of health information technologies including artificial intelligence is an advantage
  • Ability to manage CROs or external consultants
  • Ability to manage research coordinators or other research staff in the execution of research studies
  • Experience of publishing research (own or in industry capacity) is an advantage
  • Excellent problem-solving skills and initiative
  • English language required, a second language is an advantage
  • Comfortable in a hospital/surgical environment
  • Ability to travel from 25% up to 50% of the time.

Job Details:
  • Contract
  • Pay Range: $65-$70 /hr

Benefits Package: Protingent offers competitive salaries, 2 insurance plans (100% paid for employee only - HDHP plan, and a buy-up POS plan), education/certification reimbursement, pre-tax commuter benefits, Paid Time Off (PTO) and an administered 401k plan.

About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom, and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding, and exciting work opportunities for our candidates.

Meet Your Recruiter

Kalyan Krishna

I have been working in technical recruiting since 2011 and specialize in talent acquisition. My recruiting style highlights company culture and builds pipelines of quality candidates. I can help you maintain motivation until you reach your goals, and my philosophy is “don’t be afraid to start over”. I love recruiting because I like to meet and interact with exciting people. Recruiting allows me to get to know hundreds of outstanding clients and strive to leave a lasting impression on them. I love baking and gardening in my free time, and I respect women. Reach out to me to get started now! 

 

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