Boehringer Ingelheim Clinical Scientist (Remote) 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.
Accountable for operational management of clinical trials: planning, set up, conduct and reporting. Maintains oversight, ensures feasibility of trial plans, and pro-actively assesses and mitigates risks. Enforces AAI (Agility, Accountability, Intrapreneurship) approach and skills in the trial team and trial management.
As clinical trial manager (CTM), accountable for the operational management of the regional/local component of a clinical trial. Level of oversight assures achievement of trial recruitment commitment, timelines, budget and internal/external quality standards.
Communicates trial status to stakeholders/senior management on a regular basis, escalating issues as appropriate.
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:
Leads the local/regional trial team in the capacity of R/OPU Clinical Trial Manager (CTM)
Trial Preparation, Conduct and Closeout:
Selected sites conduct and deliver the trial according to the clinical trial protocol, within trial timelines, and in compliance with ICH-GCP and all other relevant external regulations.
Lead and support local trial team and investigative sites in timely preparation of required trial documents, contracts and necessary approvals.
All Regulatory Requirements are satisfied prior to trial/site initiation.
Where necessary, set up and manage external suppliers that meet requirements of local/regional trial operations.
Set up, manage and review R/OPU trial budget to ensure appropriate level of financial oversight. Timely budget updates based on trial changes.
Ensure appropriate trial-specific training of R/OPU internal and external partners in line with Trial Training Plan.
In collaboration with Site Monitoring Lead and Clinical Research Associates (CRAs), ensure:
Provision of appropriate trial oversight for the trials by monitoring compliance of trial sites and BI team to GCP, local regulations, BI SOPs (for BI staff and issue), and adherence to trial protocol.
Adequate trial supply distribution to sites.
Continuous and timely data entry and cleaning, and on time Data Base Lock (DBL).
Trial contact for CRAs, investigators and site staff.
In collaboration with Trial Resource Specialist and with support from CRAs as appropriate, ensures
collection of required documents, with timely, complete and compliant archiving of all relevant documents for the eTMF and CTR Appendices.
Management and Relationship Responsibilities:
Develop and maintain company relationships with external experts and investigational sites by coordinating and ensuring cross-functional collaboration amongst Clinical Operations and Medical Affairs on Regional/ local level, and supporting CRAs in site contacts.
Collaborates with other BI functions to support Trial Management topics and support integration across Medicine.
Participate in working groups related to Trial Management, represent trial on local and regional level, providing updates on trial within R/OPU.
Bachelor's degree from an accredited institution, plus a minimum of six (6) years of experience in clinical research, preferably in the pharmaceutical industry; Or
Master's degree or PharmD from an accredited institution, plus a minimum of four (4) years of experience in clinical research, preferably in the pharmaceutical industry; Or
PhD or MD from an accredited institution, plus a minimum of two (2) years of experience in clinical research, preferably in the pharmaceutical industry.
Solid communication, project management, networking/stakeholder management and team leadership capability.
Understanding of the scientific and/or technical components of the clinical development process, and associated regulatory requirements.
Scientific and Operational Expertise: Demonstrates technical and scientific knowledge across all aspects of clinical trial operations, including the ability to work across several trials
Leadership and Influence : Inspires local/regional trial team to achieve a common goal.
Translates complex situations to actionable parts.
Anticipates and resolves challenges through effective influencing of cross functional team members and management
Project Management: Plans, sets priorities, defines actions, makes effective use of resources, proactively strives for clarity to accomplish the business deliverables
Communication: Adapts communication style to audience to effectively influence stakeholders. Demonstrates active listening skills and cultural awareness.
Strategic Mindset: Is result-oriented with a global mindset and anticipates future needs.
When faced with issues, uses analytical thinking to provide risk-balanced solutions.
Incorporate AAI behaviors into daily work:
Accountability: Even in ambiguous circumstances, take ownership for decisions and actions.
Agility: Act with an open mind to face internal and external transformation.
Intrapreneurship: Together with our customers, come up with innovative ideas to respond to changing markets
Knowledge in relevant Therapeutic Areas is an asset.
Ability to manage clinical studies in different Therapeutic Areas is a plus.
Ability and willingness to travel domestically and internationally (10-20% of time).
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; 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.
Organization: US-BI Pharma/BI USA
Title: Clinical Scientist (Remote)
Requisition ID: 214650