Boehringer Ingelheim AD, Study Management & Conduct in UNITED STATES, United States
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 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. Independently executes assignments and initiates/leads clinical ops 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. Provides leadership to members of clinical development teams nationally and internationally when assigned.
As a supervisor, and under leadership's direction, ensures that management goals and objectives of the department are implemented by directing and supervising clinical staff,in execution of operational conduct of clinical trials (Phases I-IV) within Clinical Operations.
May serve in the appointed role of Team Member Clinical Operations.
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 trial clinical monitor (TCM), local clinical monitor (CML) or both for one or more trials responsible for operational activities inherent in planning, conduct, and completion of clinical trials 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.
As TCM, provide leadership and guidance globally to local clinical monitors for international programs regarding all aspects of clinical trial operations. The TCM function includes but is not limited to the preparation of clinical trial protocol and amendments, clinical trial report, and possible participation as member of Medical Subteam, as required.
Position is responsible for management of the trials that includes, but is not limited to: 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.
As TCM, reviews safety information including adverse event reports and trial specific data and communicates important findings to TMM and CMLs as needed.
As CML, provides leadership in the oversight and management of investigative sites in partnership with other key stakeholders/contributors, e.g., CRAs, MRAs.
As TCM, provides strategic guidance and specific criteria for site selection assessments to be used for the trial stakeholders. Works closely with internal and external partners to ensure timely deliverables, e.g., contracts, SOWs.
As CML, manage and supports relationship with TCM related to activities required for the successful implementation of the project, e.g., CTP, CTR, Investigator Meetings, DSMB and MQRM.
As TCM, influences relationship with CMLs and collaborates with medical colleagues related to activities required for the successful implementation of the project, e.g., CTP, CTR, Investigator Meetings, DSMB and MQRM.
Builds and maintains relationships cross functionally.
May supervise staff responsible for the conduct of local and international pre and post registration clinical trials to ensure efficient development and implementation of clinical trials and clinical projects assigned to these individuals. Encourages department innovation in the management of BI clinical trials.
When supervising staff, creates a performance-based team culture with clear accountability and a sense of urgency for achieving results. Supports and at times leads the recruiting, hiring, coaching, developing, motivating, managing and monitoring performance of managers and/or professionals in department specific knowledge, process and procedures.
Can be an individual contributor on related job, project, or organizational activities relevant to business needs.
Bachelor’s degree plus a minimum of 8 years experience in clinical research, preferably in the Pharmaceutical industry; or
Master’s degree or PharmD plus a minimum of 6 years experience in clinical research, preferably in the Pharmaceutical industry; or
PhD or MD plus a minimum of 3 years experience in clinical research, preferably in the Pharmaceutical industry.
Success managing projects. Supervision and management of employees desirable.
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 and 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: AD, Study Management & Conduct
Location: Americas-United States
Requisition ID: 188152