Senior Clinical Study Manager/Clinical Study Manager

Basking Ridge, NJ
Oct 04, 2021
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

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.
The Senior Clinical Study Manager role is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy.
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.
  • Provide operational input into study protocol profiles, final protocols and amendments
  • Lead document review & coordination for the protocol and amendments. Additional medical writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.
  • Lead the CRO and vendor selection process in collaboration with the study team and outsourcing procurement management.
  • Lead trial feasibility and site identification activities in collaboration with the CRO and the study team. Oversee the site qualification process.

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. Note that vendor management is not limited to the CRO, but includes 3rd party vendors (e.g. translations, trial insurance, and central laboratory, etc.).

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.

  • 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.