Senior Scientist, Clinical Operations - Hybrid

** Job Description
** This position leads the scientific 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, technical skills, and scientific acumen as part of a global, cross-functional team.
** Job Responsibilities
** Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s).  This may include
* Serving as the lead clinical scientist on the clinical trial team.
* Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with the Clinical Director.
** Other responsibilities include:
*** Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments);
Partners with the Study Manager on study deliverables.
* Ensuring CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
* Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of trial conduct.
* Providing tactical/scientific mentorship to other clinical scientist
** Core Skills
** Demonstrated ability to drive and manager scientific activities on clinical protocols. This position may represent the company through external partnerships, collaborations, and key strategic engagements.
* Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
* Ability to manage multiple competing priorities with good planning, time management and prioritization skills
* Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions
* Interact with key stakeholders across department, division, and company.
* Role requires a proactive approach, strategic thinking and leadership in driving toward study goals.
* Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division
* Applying leadership skills to processes, leading meetings, and influencing peers in a matrix environment.
* Problem solving, prioritization, conflict resolution, and critical thinking skills
* Build team capabilities through proactive coaching
* Strong communication, technical writing, and presentation skills
** Educational Experience
*** Bachelor’s degree + 5 years of pharmaceutical, clinical drug development, project management and or medical field experience
* OR Master’s degree + 3 years of pharmaceutical, clinical drug development, project management and/or medical field experience
* OR PhD / Pharm

D.
* Degree in life sciences, preferred.
*
* Required Skills:

** Accountability, Accountability, Adaptability, Clinical Data, Clinical Data Interpretation, Clinical Operations, Clinical Protocol, Clinical Research, Clinical Study Design, Clinical Trial Compliance, Clinical Trial Management, Clinical Trials, Clinical Trials Analysis, Cross-Functional Collaboration, Data Analysis, Drug Development, Ethical Standards, ICH GCP Guidelines, Life Science, Medical Writing, Motivation Management, Parasitology, Prioritization, Regulatory Compliance, Regulatory Documents {+ 3 more}
** Preferred

Skills:

** Current Employees apply

Current Contingent Workers apply
** US and Puerto Rico Residents Only:
** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please  if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  

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