Associate, Clinical Study Start Up

Location
Basking Ridge, NJ, United States
Posted
Dec 19, 2020
Ref
10613BR
Hotbed
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:

This position works with the Associate Director, Clinical Study Startup to fulfill Clinical Study Start-Up activities for Clinical Safety and Pharmacovigilance (CSPV) - PV Operations. This position will perform for CSPV, the Functional Quality Control (QC) of DS electronic trial master file (eTMF) activities for all studies. Liaise with Clinical CROs, DSI eTMF and DS CSPV (Japan) related to eTMF QC for CSPV. In addition, this position may assist the team with activities as they relate to the study startup processes such as the preparation and development of SAE Flow Plans and Addendums. Additional activities include updating Clinical Study Startup templates, PowerPoint presentations and other related guidance documents. Strong interpersonal & organizational skills with proficiency in eTMF systems, Microsoft Word, Excel, PowerPoint & Outlook preferred with the ability to work effectively with people at different levels of an organization and different cultures.

Responsibilities:

Sponsor Functional QC for eTMF - perform the CSPV portion of the Sponsor Functional Quality Control (QC) of electronic trial master file (eTMF) activities for all studies, programs, as applicable. Will work closely with Clinical CROs, DSI eTMF and DS CSPV (Japan) to ensure quality standards are met within eTMF for CSPV.
Functional Owner of study specific TMF content and covers both TMF content creators and the responsible DS Companies recipient of TMF content for a clinical trial.
Responsible for the creation, receipt, processing, and timely upload/filing of TMF content into their defined repository, ensuring the records are correctly formatted, named, as defined in the study specific TMF Management Plan and TMF Inventory.
Liaise with study teams, CROs in order to coordinate the flow of trial documentation to the Trial Master File for CSPV. Co-ordinate and manage the receipt, classification, filing and archiving of documentation for all TMF studies on behalf of CSPV.
Responsible to perform ongoing quality checking activities at pre-defined time points which ensure TMF quality and completeness as well as regulatory compliance as defined in the study specific TMF Management Plan.
If applicable, submit paper original documents with wet ink signatures to TMF Operations.

Clinical Study Startup Activities - assist the Clinical Safety Startup team with activities as they relate to the study startup processes such as the preparation and development of SAE Flow Plans and Addendums, as applicable.

Document Management and Development Activities - additional activities include updating Clinical Study Startup templates, PowerPoint and other related guidance documents, as applicable.


Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

Bachelor's Degree or a related area is required, or equivalent years of work-related experience considered in lieu of a degree

1 or More Years' experience for Bachelor's degree: pharmaceutical or drug safety/pharmacovigilance or clinical study trial experience

4 or more years' experience in lieu of a degree: drug safety/pharmacovigilance or clinical study trial experience

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
Associate, Clinical Study Start Up

City
Basking Ridge

Functional Area
CSPV

State
New Jersey