RM- Data Science Practitioner- Data Science Program Lead
4 weeks ago
Description
Remote: Yes
Local: No
Education: Bachelors degree in business, management information systems, computer science, life sciences or equivalent.
PMP Certification or Lean Six Sigma Green Belt highly desired
Experience: Yes
Looking for a Program Lead II, with an experience range of 10 years.
They also prefer someone with Immunology therapeutic area experience
End to end domain knowledge and experience in data management is required
Experience managing a clinical study is required
Looking for candidates with demonstrated leadership skills, both internal and with external (with client teams)
Looking for a candidate with project management skills creating timelines, metrics and KPIs
Data Science ---
ligns Data and Statistical Science study teams with program- and study-level strategies. For assigned studies, leads the Data and Statistical Science Study Team and represents Data Science as a member of the cross-functional study team. For assigned studies, acts as single point of contact and accountable operational lead from Data & Statistical Science. Coordinates associated Data Science study teams to meet operational objectives. Engages and connects global functional and cross-functional teams. Interacts with and influences cross-functional team members to achieve program and study objectives. Utilizes operational analytics and project management tools to optimize execution of programs and studies, to manage internal and external resources, to track study progress, and to prepare study status reports. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions. Ensures adherence to federal reg
ligns DSS study teams with program- and study-level strategies. Assigned programs may include
programs that are of low complexity and size. For assigned programs and studies, leads the DSS
Study Team and represents DS as a member of the cross-functional study team
For assigned programs and studies, acts as single point of contact and accountable operational
lead from DSS. Coordinates associated DSS study teams to meet operational objectives. Engages
nd connects global functional and cross-functional teams at the study level
Interacts with and influences cross-functional team members to achieve program objectives
Utilizes operational analytics and project management tools to optimize execution of programs and
studies, to manage internal and external resources, to track study progress, and to prepare study
status reports. Anticipates and identifies issues that could affect timelines or quality and develops
options and solutions
Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices
(GCPs), ICH Guidelines, Client Standard Operating Procedures (SOPs), and to functional quality
standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related
to clinical development. If assigned, participates as the DS study owner in regulatory inspections
nd internal quality audits
Participates in oversight of vendors and provides feedback related to clinical trial operations,
issues, and trends in performance
Responsible for coaching and mentoring team members
Leads DSS innovation and process improvement initiatives and participates in cross-functional
initiatives
Conducts study execution lessons learned across functions
May include indirect supervision of employee as well as supervision of work of contract resources
dditional Job Details:1 - Clinical Data Management (CDM) (P3 - Advanced) | 2 - Clinical Trial Management Processes (P3 - Advanced) | 3 - Program and Project Management (P3 - Advanced)
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