Associate Director Clinical Trial Support Management in Basking Ridge, New Jersey at DSI

Date Posted: 1/19/2020

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years and Counting!

With over 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 hypertension and thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research and development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart and kidney diseases, and other rare diseases.

Job Summary:

Job Summary (Describe the purpose of the job in 1-2 sentences)
The Associate Director, Clinical Trial Support, will supervise a group of Senior Clinical Study Associates (CSAs) who assist in planning and in the execution of clinical studies in adherence to the protocol, Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The leader will ensure the CSA group provides clinical administrative support to study teams and support interactions with the Contract Research Organizations (CROs) and other vendors conducting the study to help monitor compliance with Daiichi Sankyo (DS) Quality Oversight measures. A key focus will be the oversight of, and interactions with, CROs and other external vendors to ensure TMF deliverables are maintained according to the timeline, budget and quality metrics set forth by the Study team and within the TMF Management Plan. Responsibility for staff training, performance management, setting individual employee goals and career growth opportunities. The leader will also manage contract staff, as required.
Oversees CSA recruitment and resourcing, ensuring proper timing and allocation of resources to projects to achieve study timelines and deliverables.
Contributes to development of strategic plans for Clinical Development Operations (CDO) and helps to translate strategic decisions into actionable operational support models.
Contributes to development of departmental goals and objectives to achieve corporate goals.
Partners with other functional areas within CDO, with other functionals across DS and with CROs/vendors to ensure clinical trials are executed on time, within budget and with quality.
Defines and monitors key performance indicators and departmental metrics for CDO and identifies opportunities to optimize processes and procedures (SOPs, Work guidance).
Contributes to oversight of vendors, including issue remediation and governance.
Participates in departmental and cross-functional process improvement initiatives, as required

Responsibilities:
  • Oversight of the CSA team’s activities in the transmission of trial and site level document to the Daiichi Sankyo Document Control Center (DCC) in support of the Trial master File (TMF) and in the reconciliation of the TMF document trackers generated by the CRO with the document archive. Ensure appropriate escalation and mediation plans are in place should issues arise.
  • Ensure a robust process flow is in place in the oversight of CRO collection of essential study documents at study startup, study maintenance and at follow-up after study and site close-out (e.g. document retrieval, collection of study documents for CSR appendices).
  • Ensure consistent distribution of key study documents to the CRO and vendors when appropriate.
  • Oversee clinical administrative support is in place for the study teams. This may include preparing meeting logistics, distributing agendas, and minutes for study team meeting, meetings with Academic Research Organizations (AROs), and meetings with CRO and Investigator Meetings.
  • Collect information and coordinate with DS Regulatory Operations to post trial information on required public forums (eg.clinicaltrials.gov).
  • Develop role-based training and develop recommendations for areas of improvement and innovation (study, or departmental level). Associate director will ensure an onboarding plan for all new staff is in place.
  • People management; Supervision of direct reports as well as contractor staff. In addition to providing ongoing instruction, direction in support of study/program level deliverables, the associate director will conduct performance evaluations and ensure robust development plans are in place for all of their direct reports.
Qualifications
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:
  • Minimum: Bachelor’s degree or associate nursing degree/diploma with relevant clinical development. Master’s degree preferred.
  • 7 years’ relevant experience is required with a BS; 5 years’ relevant experience with a MS
  • 2-3 years of people management experience is required.
  • Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO).
  • Time spent directly in a medical environment (e.g. as a Study Site Coordinator) is also considered relevant.
Ability to travel up to 10%

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.