Boehringer Ingelheim Clinical Scientist, Study Mgmt & Conduct - Ridgefield, CT 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.
Provide critical support of operational planning, implementation, conduct, and completion of clinical trials. Provide experienced judgment and recommends action(s) in response to operational clinical trial issues. Seeks input on issues requiring medical judgment and/or management input. With minimal guidance executes assignments and may initiate/lead clinical operations project team through effective partnering and influencing key contributors in collaboration with Cross Functional Partners in Clinical System & Information Management (CSIM), Clinical Resource Management (CRM) and Clinical Field Operations (CFO) Departments and Therapeutic Area Groups (TAGs) in Clinical Development and Medical Affairs (CDMA) to assure a closely coordinated program of activities based on common objectives focusing on quality and efficiencies to ensure the final goals of assigned projects are met. Develops and maintains relationships with investigators, vendors, contract research organizations, and members of other departments.
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:
Functions as local clinical monitor (CML) responsible for operational activities inherent in planning, conduct, and completion of clinical trials (Phases I-IV) by leading the clinical operations project team through effective partnering and influencing key contributors (e.g., CFO, CSIM, CRM and CTM) and other cross functional groups as necessary. May participate as member of Medical Subteam, as required.
Position is responsible for management of the trials that includes, but is not limited to: managing selection of investigational sites, preparing and managing clinical supplies, timelines to meet established goals, clinical trial documentation (e.g., CTMS, CTMF, data integrity), develops and executes tools in support of trial activities, develops and implements communication plan with internal and external partners, and trial budget. Manage adverse event reporting.
Keeps management informed of trial progress and resource needs by use of effective communications. Seeks input on issues requiring special expertise, e.g., medical judgment. Successful implementation of protocol deliverables and in meeting other key performance indicators.
Manage and supports relationship with Trial Clinical Monitor (TCM)and functional partners related to activities required for the successful implementation of the project, e.g., CTP, CTR, Investigator Meetings, DSMB and MQRM.
Responsible for the oversight and management of investigative sites in partnership with other key stakeholders/contributors, e.g., Clinical Research Associates (CRAs), Medical Research Associates (MRAs) and effectively supports and leads activities of MRAs assigned to trials.
Adherence to government regulations company SOPs, local working instructions and role specific training relevant to the operational conduct of clinical trials.
Can be an individual contributor on related job, project, or organizational activities relevant to business needs.
Bachelor’s degree plus a minimum of 6 years experience in clinical research, preferably in the Pharmaceutical industry; or
Master’s degree or PharmD plus a minimum of 4 years experience in clinical research, preferably in the Pharmaceutical industry; or
PhD or MD plus a minimum of 2 years experience in clinical research, preferably in the Pharmaceutical industry.
Success managing projects,
understanding of the scientific and/or technical components of the clinical development process and regulatory requirements.
Ability to use and learn system applications, e.g., MS Office, document management systems.
Good oral and written communication skills; ability to work independently and as part of a team; strong analytical and problem solving skills.
Ability and willingness to travel, domestic or international. (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
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: Clinical Scientist, Study Mgmt & Conduct - Ridgefield, CT
Requisition ID: 1815577