Accountable for operational management of clinical trials: planning, set up, conduct and reportingMaintains oversight, ensures feasibility of trial plans, and pro-actively assesses and mitigates risksEnforces 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 trialLevel 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 customersOur global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies` successWe realize that our strength and competitive advantage lie with our peopleWe support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balanceOur 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 oversightTimely 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.
Clinical scientist requirements:
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 stakeholdersDemonstrates 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).
Associate director:
Description:
Accountable for operational management of clinical trials: planning, set up, conduct and reportingAs leader of the trial team, maintains oversight, ensures feasibility of trial plans, and pro-actively assesses and mitigates risksEnforces aai (agility, accountability, intrapreneurship) approach and skills in the trial team and trial managementMay serve as clinical trial manager (opu role) and/or clinical trial leader (global role)May mentor more junior ctmsCommunicates trial status to stakeholders/senior management on a regular basis, escalating issues as appropriate.
Associate director, clinical operations
Requirements:
Bachelor’s degree from an accredited institution in life sciences or a related area plus a minimum of eight (8) years’ experience in clinical research, preferably in the pharmaceutical industry; or
Master’s degree or pharmd from an accredited institution plus a minimum of six (6) years’ experience in clinical research, preferably in the pharmaceutical industry; or
Phd or md from an accredited institution plus a minimum of three (3) years’ experience in clinical research, preferably in the pharmaceutical industry.
Advanced degree (ms, phd, md, pharmd) strongly preferred
Strong communication skills in complex cross-functional matrix structuresEnforce aai approach and skills in the trial team and trial managementArticulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and actionHighly developed receptive communication skills, cultural sensitivity
Experience in therapeutic area relevant in bi pipeline is desirable
Understanding of major regulations (us fda, ema and pmda)
Familiarity with guidelines and standard of care is desirable
Strong and in-depth understanding of team work and high-performance teams
Working in multi-cultural environment and in-depth understanding of corporate culture and cross-culture dynamics
Acumen as mentor/coach
Technical expertise: demonstrates knowledge and expertise (plus ta) across all aspects of clinical trial operations and executionDimensions of trial complexity include protocol, patients, sites, countries, vendors
Leadership and influence: candidate`s skills and capabilities in addressing complex situations, resolving conflicts, horizontal and vertical influencing.
Communication: articulates and aligns business strategy/plan on an ongoing basis, ensuring alignment between words and actionHighly developed receptive communication skills, cultural sensitivity
Strategic mindset: big picture thinker, able to manage through ambiguityIntegrates study strategy with overall ta portfolioEmbraces cross functional initiatives, applying innovative learnings
Coordination and oversight: candidate`s skills and capabilities in setting priorities, managing pace of activities, and efficient usage of resources
Ability and willingness to travel domestically and internationally (10-20% of time)
Eligibility requirements:
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.
Compensation: this position offers a base salary typically between 111,900 and 139,900There is opportunity to consider higher compensation above this range based on business need, candidate experience and or skillsThe position may be eligible for a role specific variable or performance based bonus and or other compensation elementsFor an overview of our benefits please click here.
Who we are:
At boehringer ingelheim we create value through innovation with one clear goal: to improve the lives of patientsWe develop breakthrough therapies and innovative healthcare solutions in areas of unmet medical need for both humans and animalsAs a family owned company we focus on long term performanceWe are powered by 50.000 employees globally who nurture a diverse, collaborative and inclusive cultureLearning 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 cultureWe embrace diversity of perspectives and strive for an inclusive environment, which benefits our employees, patients and communitiesAll qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; 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.
Job - clinical operations primary location - americas-us-ct-ridgefield organization - us-bi pharma/bi usa schedule - full-time
