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US_Specialist II, Clinical Systems

Company: Boehringer Ingelheim
Location: Danbury
Posted on: August 1, 2022

Job Description:

Description:Description\: The Specialist II is responsible for PI Vetting, user system support and data entry into local/global Clinical Operations (CO) Systems. This support requires a close working relationship with Clinical Teams to maintain a clear understanding of support needs. Responsibilities also include support of the growing base of US users in Medical, DRA, DSI, Financial Controlling. Under the direction of the Sr. AD Clinical Systems, follows established processes to screen, maintain and validate investigator information; perform database quality checks; analyze and suggest investigators to be considered for specific trials. Conducts investigator screens and is a key supporting resource for managers in Clinical Systems. The position is also responsible for contributing to the development of best practices within the Clinical Systems group and the optimal utilization of the systems at BIPI. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees Duties & Responsibilities\:

  • Accountable for Investigator vetting and maintaining timely and accurate information of pre-qualified investigators in BI systems. - Works with the appropriate Clinical Systems management and/or team leads to ensure BI/FDA procedures and guidelines are adhered to. - Independently identifies and solves standard problems; analyzes and offers solutions to more complex problems.
  • Building the Investigator/site vetting process
  • Development of generic screen questionnaires, Operations Manual, and Working Instructions
  • Professionally and ethically respond to inquiries that the company receives directly to Service mailboxes or via www.clinicaltrials.gov from prospective investigators, sites, SMOs, and networks (track inquiries and actions taken)
  • Respond to internal inquiries from Clinical Operations and other medical groups and take appropriate action
  • Provide training to employees / contracted employees on vetting and screening process to understand the vetting results.
  • Request, retrieve, review, and negotiate with site to finalize BI investigator generic screen questionnaire and applicable attachments. Vet the PI and then process finalized generic screen to include proper filing and entry into Investigator Database as IDM.
  • Support Site Operations to vet PIs as needed for specific trials and document in Investigator Database and other tools as applicable
  • Refer PIs (pre-screened and vetted) to Site Operations as they are found appropriate for trials which are recruiting PIs/sites
  • Partner with Medical groups (CDMA, QMM&R, CMTTS, RDMG, CTCM) to obtain internal business intelligence ratings, alerts, Scientific Expert or KEE status for investigators and sites.
  • Work with Site Operations to determine which trials are actively seeking PIs/sites and maintain a tracker of available and closed trials
  • Partner with Site Operations when they are mining for a trial
  • Work with external vetting vendor (currently Baker Street Associates) and provide vetting info to CMLs and/or Feasibility Analysts.
  • Research and investigate into FDA restrictions and compliance sources in order to identify qualified investigators
  • Create, update investigator data and site data to the investigator database (BI CTMS) based on new or updated Generic Screen, Site Profile Form or / and any related documents from internal and external sources.
  • Create, update investigator data and site and staff data in BI CTMS based on the Reg. documents (e.g. FDA 1572)
  • Update accurate investigator site information to Clinical Trial Management System (BI CTMS) from the pre-designed template.
  • Create, update spends data and site data in AGS360 based on the vendor submitted trial spend data.
  • Respond to PI / site inquiries, External and internal referrals, internal request regarding PIs and sites vetting requests, CTMS Study site set up or update requests.
  • File, retrieve and distribute investigator and site related documents based on the business process.
  • Review the CTMS request and investigator information forms according to established quality standards for completeness and accuracy.
  • Follow the business process to complete the CTMS study site template request properly.
  • Resolve quality issues with clinical personnel by requesting corrections and if needed clarification in an expedited manner
  • Provide support for ad-hoc requests from the supporting areas.
  • Work closely with clinical teams and individuals to provide proactive/as needed support on relevant systems and tools to ensure timely knowledge and best use of the tools.
  • Provide first tier user support by responding to help desk requests.
  • Provide Systems and process expertise to assist users in troubleshooting data or process issues.
  • Assess the effectiveness of current tools/systems/processes utilized by Clinical Systems team and recommend solutions/ideas for further process improvement.Requirements\:
    • Bachelor's degree from an accredited institution required
    • A minimum of three (3) years of professional, related experience
    • Strong analytical skills and pro-actively use good judgment to solve standard problems
    • Strong organizational skills and the ability to multi-task under pressure
    • Proactive communicator, with the ability to summarize information in an efficient and effective manner.
    • Ability to easily adapt to new systems/technology
    • Candidates independently investigate and solve standard problems, seeking guidance from others as needed.
    • At minimum candidates should have strong Word and Excel skills. - Adobe Acrobat Professional and experience using databases is a plus.Desired Skills, Experience and Abilities\:
      • Preferred but not required\: - basic knowledge and industry experience; an ability to evaluate data and scientific literature; basic understanding of FDA/ICH/GCP/HIPAA regulations; experience as an MRA, study coordinator, CRA, or Reg Doc administrator.
      • Familiarity with the supported Medical applications and an understanding of technologies used by these applications is preferred.This position will require individuals to be fully vaccinated against -COVID-19 -or have an approved medical or religious accommodation. Click - -for more information on the vaccine mandate and -COVID-19.Eligibility Requirements\:
        • Must be legally authorized to work in the United States without restriction.
        • Must be willing to take a drug test and post-offer physical (if required)
        • Must be 18 years of age or older Who We Are\: At Boehringer Ingelheim we create value through innovation with one clear goal\: to improve the lives of patients. We develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animals. As a family owned company we focus on long term performance. -We are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive culture. -Learning and development for all employees is key because your growth is our growth. Want to learn more? - Visit boehringer-ingelheim.com and join us in our effort to make more health. Boehringer Ingelheim is an equal opportunity global employer who takes pride in maintaining a diverse and inclusive culture. We embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communities. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

Keywords: Boehringer Ingelheim, Danbury , US_Specialist II, Clinical Systems, Healthcare , Danbury, Connecticut

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