Senior Study Manager - Women's cancer

Job Description

Job Summary:
This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to 
demonstrate your leadership and technical skills as part of a global, cross-functional team. You will apply project management, communication, and collaboration skills in 
support of our clinical trials.

Job Responsibilities:

• Responsible for the operational planning, feasibility, and execution of a clinical trial.

• May serve as the clinical trial team lead

• May lead team in key study planning, development, and execution elements (e.g., data management 

• deliverables, trial level plans/timelines, country/site selection, site materials, system updates, 

• investigator

• meeting planning, communication plans, preparation of status update reports, study close out 

• activities).

• Leads team for timeline management, risk identification and mitigation, issue resolution.

• May facilitate and collaborate with key internal/external stakeholders (e.g., study team, country 

• teams, vendors, committees) in support of clinical study objectives.

• Accountable for managing any study specific partners and/or vendors.

• Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)

• Ability to manage multiple competing priorities with good anning, time management and 

• prioritization skills

• Solid understanding of the princi es of project planning & project management

• Good 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. Role requires a proactive approach and leadership driving toward study goals.

• Applying leadership skills to processes, leading meetings, and influencing peers in a matrix environment.

• Problem solving, prioritization, conflict resolution, and critical thinking skills

• Strong communication, writing, and presentation skills

• Intermediate knowledge in Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc.)

Education/Experience:

• Bachelor's Degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience

• OR Master's Degree +3 year of pharmaceutical, clinical drug development, project management, and/or medical field experience

• OR PhD/PharmD Degree

• Degree in life sciences, preferred.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

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

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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