Senior Clinical Study Manager

Location
Basking Ridge, NJ, United States
Posted
Feb 09, 2021
Ref
10655BR
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
Join a Legacy of Innovation 110 Years & Counting!

With over 100 years of scientific expertise & a presence in more than 20 countries, Daiichi Sankyo & its 15,000 employees around the world draw upon a rich legacy of innovation & a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension & thrombotic disorders, under the Group's 2025 Vision to become a "Global Pharma Innovator with a Competitive Advantage in Oncology,"

Job Summary:

The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to Good Clinical Practices (GCPs), appropriate SOPs, FDA regulations/EU Directive, and ICH guidelines.

The Senior Clinical Study Manager will have routine interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail are required and are equally important.

Responsibilities:
  • Responsible for supporting an Inspection readiness team comprised of members of various departments to ensure robust plans are in place.
  • Responsible for creating and maintaining storyboards with key study members for critical incidents and processes to be used during an inspection.
  • Responsible for assessing study eTMF for completeness/readiness and working with study teams to address and document gaps as appropriate
  • Support and eventually lead investigations into quality issues including event analysis, root cause analysis, corrective actions, and documenting such occurrences
  • Support the development of tools and support materials to ensure GCOP remains inspection ready including but not limited to checklists, inspection guides, training materials
  • May serve as the key individual to triage and coordinate inspection requests and reviewing information and documents in the inspection preparation/staging area

Study Management & Leadership
  • Has primary accountability for operational study level time, cost and quality deliverables.
  • Lead the development of the clinical study plan including critical path activities and interdependencies for assigned clinical study utilizing Microsoft Project or equivalent.
  • Lead the creation of the cross-functional Clinical Study Oversight Plan (CSOP) under the guidance of the study team leader and take a leadership role in ensuring study team adherence to the CSOP and manage the overall implementation and documentation of the CSOP, including activities conducted by CROs and vendors.
CRO, 3rd Party Vendor Management and Oversight
  • Responsible for the oversight, performance, and management of CRO and 3rd party vendors to ensure compliance with Daiichi Sankyo's quality measures and adherence to scope of work within timelines and budget at a task level. Specifically track operational study timelines and monitor operational performance metrics trough the life of the study; Identify issues and propose solutions.
  • Responsible for ensuring that the CRO(s) provide timely input and generate documents in a timely manner and with quality (e.g. communication plan, site monitoring plan, etc.) as per study plan.
  • Responsible for overseeing CRO study start-up activities and coordinating with functional groups to ensure that essential site documents are collected, and sites are initiated per study plan. Oversee and track site initiation and enrollment activities at the country and site level and develop mitigation strategies in collaboration with the CRO.
  • Coordinate with the CRO to prepare and execute meetings including Vendor kick-off meetings, study team meetings, regional team meetings, investigator meetings and training.

Knowledge Management
  • Support Department in codifying existing knowledge and best practices; Prepare training in area of expertise. Make recommendations for areas of improvement and innovation (study, or departmental level). Educate the team on adherence to SOPs, GCPs and on best application of operational tools.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • A Bachelor's degree (preferred in Life Sciences) is acceptable. 5-6 years' relevant experience is required with a BSc
  • Experience in clinical operations methods and processes in industry setting required.
  • Experience considered relevant includes clinical or basic research in a Pharmaceutical company, ARO, CRO. CRA experience is preferred.

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
Job Title
Senior Clinical Study Manager

City
Basking Ridge

Functional Area
Global Clinical Operations & Planning

State
New Jersey