Associate Director, Study Manager
3 weeks ago
This position participates in the strategy and leads the operational planning and execution of one or more clinical trials. In this position, you will have the opportunity to demonstrate your advanced leadership and technical skills as part of a global, cross-functional team. You will build and coach your team in the development of project management, communication, and collaboration skills in support of our clinical trials.
**Responsibilities**:
- Responsible for the operational planning, feasibility, execution and conduct of clinical trial(s).
- Serves as the Clinical Trial Team lead
- Leads and directs teams in key study planning, development, and execution elements (e.g. operational reviews, issue escalation/mitigations, presentations at Sr. Management meetings, program level cross functional meetings and governance).
- Responsible for facilitating and collaborating with key internal/external stakeholders (study team, subsidiary country teams, vendors, committees, etc.) in support of clinical trial objectives.
- Liaises with partners, vendors, and vendor management team.
- Review and provide clinical operations input into relevant clinical documents such as the protocol and other documents as appropriate.
- Builds talent and capabilities of junior team members through proactive coaching, mentoring and development opportunities.
- May include management of direct/indirect reports including assignment of resources, professional development, and performance management
**Core Skills**
- Strong knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
- Proven ability to manage competing priorities and effectively delegate and assign activities to meet the business needs
- Ability to develop short and mid-range project plans that are realistic and effective at meeting goals.
- Strong analytical skills to drive operational milestones
- Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division
- Interact with key stakeholders across department, division, and company. Roles requires a proactive approach, strategic thinking and leadership driving toward study goals.
- Demonstrated leadership skills in programs & processes, leading meetings and influencing peers and direct/indirect reports in a matrix environment.
- Problem solving, prioritization, conflict resolution, and critical thinking skills
- Strong communication, writing, and presentation skills
- Proficient knowledge in Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc.)
**Experience**
- Bachelor’s degree + 9 years OR Master’s + 6 years OR PhD/PharmD + 2 years Pharmaceutical and/or clinical drug development experience. Degree in life sciences, preferred.
**NOTICE** **FOR** **INTERNAL** **APPLICANTS**
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
MRLGCTO
eligibleforERP
CSSMHiring
CSSMOncology
**Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.**
**US and Puerto Rico Residents Only**:
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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