Feasibility Manager (Remote)

BoehringerPRD•Brampton, ON

6d•Remote

About The Position

The Feasibility Manager is responsible for the development and deployment of comprehensive country and site feasibility assessments across Boehringer trials and programs. This role ensures recommendations are tactically feasible and considerate of the indications/assets from a holistic industry perspective. In close alignment with internal stakeholders, this role identifies highly capable investigators/sites to meet study requirements and business needs. The Feasibility Manager applies expertise as a systems and database subject matter expert to improve integrity & quality of feasibility outputs. The incumbent utilizes data and available resources to ensure site selection goals can be met and patient recruitment goals are obtainable and strategic in accordance with upcoming BI trial landscape. This role will be an active representative of Study Site Start-up & Management (SSU&M) including on local & corporate process improvement projects & initiatives. 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 several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Requirements

Bachelor's Degree required; Advanced science/clinical degree (PharmD, M.D., DNP, DO, Ph.D., RN, Master’s) preferred.
Experience in the regulated pharmaceutical or healthcare industry required; a minimum of at least four (4) years’ experience is preferred.
Two-plus (2+) years Country/site clinical trial feasibility experience.
Thorough understanding of all phases of drug development (I-IV).
Understanding of federal regulations pertaining to IND and NDA regulations.
Experience working with cross-functional, matrix structured teams/organizations.
Previous project management experience required OR demonstrated ability to gain respective skills, which include emotional intelligence, ability to handle stress and make good decisions, strong planning and organization, ability to multi-task, and manage and support clinical teams & timelines.
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.

Nice To Haves

Advanced science/clinical degree (PharmD, M.D., DNP, DO, Ph.D., RN, Master’s) preferred.

Responsibilities

Leads data-driven, US country feasibility analysis (study, project, TA level) with input from cross-functional stakeholders and SMEs.
Performs analyses and provides clear outputs with applicable recommendations.
Responsible for holding related meetings & maintaining documentation.
Develops and conducts trial and project feasibilities.
Develops clear, comprehensive Country Feasibility assessment outputs.
Presents outputs with applicable recommendations to key stakeholders & management to align on global feasibility responses and US patient/site allocations.
Recommends and develops country feasibility solutions to aid in future Boehringer trials needs/assessments.
Constructs site list for site feasibility outreach utilizing tools available and incorporating input from stakeholders.
Executes site feasibility with sites, networks, strategic alliances.
Identifies opportunities to expand the pre-qualified potential investigator/network pool in anticipation of future indications by TA.
Identifies, evaluates, and recommends a sufficient supply of pre-qualified investigators for assigned trials with a focus on data driven site recommendations.
In close alignment with the medicine team, guide the development and manage the collection of trial specific questionnaires/screens and conduct of site scoring.
Identifies and recommends sites/networks as opportunities for alliances.
Supports cross trial/indication/TA site feasibility needs and able to execute accordingly.
Maintains and updates required systems, databases & shared locations to ensure visibility to feasibility outputs throughout BI.
Ensures documentation is maintained in accordance with Corporate/Local procedures.
Functions as an early adopter/advanced user of data sources and tools which support feasibility.
Represents US CDO on the review & impact of data sources and tools.
Partners with US & Global functions to ensure alignment of and operational planning and execution of clinical trials.
Provides regional contributions to local asset teams.
Communication of team objectives and capabilities & enhances reputation of SSU&M to a broader internal audience (I.e., CDMA and Commercial organizations).
Partners with internal stakeholders to collaborate on and manage operational site/service provider relationships.
Represents BI to enhance external reputation.
Performs all company business in accordance with regulations (e.g. EEO, FDA, ICH, DEA, OSHA, PDMA, EPA, PhRMA, etc.) and Company policy and procedures.
Immediately reports all noted/observed violations.
Demonstrates high ethical and professional standards with all business contacts to maintain Boehringer's excellent reputation within the industry environment.
Represents Site Planning & Optimization on projects and work streams, for process improvements or input which support company goals or objectives.