Boehringer Ingelheim Feasibility Manager in RIDGEFIELD, Connecticut
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.
Develops and implements regional profiling to bolster and sustain pre-qualified potential investigators to support the BI pipeline. Oversees the development of comprehensive OPU Feasibility assessments for BIPI Phase I-IV interventional studies and ensures recommendations are tactically feasible. Applies knowledge to improve efficiencies, integrity, quality, standardization and availability of data to ensure site selection goals are met. Acts as a liaison for vendors and contract resource organizations (CRO). Manages communications, relationships, activities, and expectations during study feasibilities within Clinical Operations and with cross-functional partners and Corporate.
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:
Oversees daily activities and provides mentoring to staff.
Develops and maintains feasibility metrics and status reports (ex. process cycle time, quality of recommendations, workload distribution, etc) to support data-driven decisions.
Partner with cross-functional stakeholders and SMEs to leverage knowledge, identify operational efficiencies, and implement process improvements.
Designs study specific questionnaires for the assessment of country specific feasibility information including but not limited to protocol design, investigator, site and trial capabilities, patient population, etc.
Leads strategic and tactical feasibility development of Regional Profiling.
Recommend preferred sites/networks by TA and/or indication and successfully present the business rationale in internal forums.
Identify opportunities to expand the pre-qualified potential investigator pool in anticipation of future indications by TA. Manage the execution and/or implementation
Guides the development/implementation of processes to conduct TA screens in collaboration with SMEs.
Proactively identify and share information about current events, legislation, and regulations that may impact site selection.
Participate in industry related conferences at the request of management, present insights to ClinOps colleagues upon return.
Implement a framework of metrics to inform opportunities for operational improvement.
Performs all Company business in accordance with all regulations (e.g. EEO, FDA, ICH, DEA, OSHA, PDMA, EPA, PhRMA, etc) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIPI's excellent reputation within the medical and pharmaceutical community.
Ensure feasibility activities are standardized across studies and TAs. Responsible for developing and maintaining training, guidelines, and SOPs for feasibility operations as directed.
Ensure documentation is maintained in accordance with Corporate/Local procedures.
Degree in Life Sciences (BA, MS, PhD) or Diploma in Nursing (RN) or degree in Pharmacy.
Seasoned professional with a minimum of seven (7) to nine (9) years’ experience in the pharmaceutical/biotech industry.
A minimum of one (1) to two (2) years supervising personnel is preferred.
One (1) to three (3) years’ experience leading projects is required.
Candidates should have experience managing global and regional feasibilities.
Experience as a Clinical Monitor, Field Monitor, or Site Manager is highly desired.
Must have basic knowledge and experience in clinical medicine with an ability to evaluate data and scientific literature; must understand and implement FDA/ICH GCP regulations; in addition to advanced understanding of sponsor criteria necessary to qualify sites and staff to perform clinical human trials Phases I-IV.
Advanced time management and project management skills are required.
Excellent analytical skills and critical thinking abilities required, including an ability to anticipate issues and pro-actively problem-solve.
Candidates must be proactive communicators, with strong interpersonal/negotiation skills.
Must be capable of summarizing complex issues/data to effectively communicate with varying levels of management.
Strong organizational skills and ability to accomplish multiple tasks of varied complexity simultaneously and under pressure.
Familiar with the supported Medical applications and an understanding of technologies used by these applications.
Proficient in Word, Excel, Adobe Acrobat Professional.
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
Boehringer Ingelheim is one of the world’s top 20 pharmaceutical companies and operates globally with approximately 50,000 employees. Since our founding in 1885, the company has remained family-owned and today we are committed to creating value through innovation in three business areas including human pharmaceuticals, animal health and biopharmaceutical contract manufacturing. Since we are privately held, we have the ability to take an innovative, long-term view. Our focus is on scientific discoveries and the introduction of truly novel medicines that improve lives and provide valuable services and support to patients and their families. Employees are challenged to take initiative and achieve outstanding results. Ultimately, our culture and drive allows us to maintain one of the highest levels of excellence in our industry. We are also deeply committed to our communities and our employees create and engage in programs that strengthen the neighborhoods where we live and work. Boehringer Ingelheim, including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA, Boehringer Ingelheim Animal Health USA, Inc., Merial Barceloneta, LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmative action employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender identity or expression; affectional or sexual orientation; disability; veteran or military status, including protected veteran status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment verifications and drug screenings.
Organization: US-BI Pharma/BI USA
Title: Feasibility Manager
Requisition ID: 190162