Associate Director, Regional Site Engagement Manager

Location
Basking Ridge, NJ, United States
Posted
Nov 20, 2020
Ref
10436BR
Hotbed
Pharm Country
Required Education
Doctorate/PHD/MD
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 Regional Site Engagement Manager (RSEM) will be in the US and will serve as the Daiichi-Sankyo (DS) point of contact across multiple studies at key sites ensuring coordination of activities across multiple DS functions. The RSEM will coordinate with the Operations Managers, Study Team Leader, Global Clinical Leads (GCL) and the Medical Science Liaisons (MSL) in developing both regional and site-specific engagement strategies. The individual will develop site specific rules of engagement, identify key site contacts as well as develop an understanding of the site's clinical trial infrastructure to identify opportunities to better support their conduct of Daiichi-Sankyo studies. The RSEM will also support successful delivery execution of clinical studies, at assigned sites, in one or more geographic regions, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.

Responsibilities:

Site Engagement

Support identification of key sites of focus to strengthen site relationships, enhance clinical trial conduct and develop a site-specific integrated plan which will include but not limited to site communication plan and rules of engagement.

Coordinate a holistic and integrated strategy for engaging key sites on strategic, scientific and operational plans in assessing the site's ability to participate in future studies.

Daiichi-Sankyo point of contact for assigned sites. Develops a portfolio understanding of site capabilities, clinical trial conduct infrastructure and identify site contacts for Daiichi-Sankyo.

Will develop a site playbook in support of site engagement with clear responsibilities and expectations for all site-facing roles.

Ensure alignment with CROs on roles and responsibilities in support of site activities in support of study conduct and fostering site engagement.

CRO and Quality Oversight

Support study teams and clinical trial sites in tracking CRO(s) performance at key sites to ensure adherence to scope of work within timelines. Specifically track short-term operational study timelines and monitor operational performance metrics through the life of the study; Identify issues and propose solutions. Proactively assess potential risks to the study and propose mitigation plans.

Contribute toward the creation of the Clinical Study Oversight Plan (CSOP) and when required, conduct quality oversight monitoring (CROOM) visits as outlined in QOP. Be able to identify areas of concern at key sites and either resolve, propose solutions, or bring to the attention of the supervisor. Coordinate and liaise with Daiichi Sankyo QA on audit and site related CAPA activities as required.
Support QA and regulatory site inspections.

Key Site Oversight

At key sites, assist the study team in the selection, onboarding and establishing timelines for study start-up activities.
Works with the study team to include the Study Team Leader, Operational Managers, Clinical Development team (GCL, PS, CS) and the Medical Science Liaisons (MSL) to engage directly with site to maintain relationships throughout the course of the trial and develop future opportunities.
Expedites the pre-study and study initiation processes including support of Pre-Study Evaluation and Site Initiation Visits in collaboration with Study Managers and/or CRO CRAs, where applicable, to orient and train site personnel regarding the protocol and applicable regulatory requirements.

Critically reviews and analyzes site activities through targeted risk-based site contacts and on-site visits to monitor study sites protocol execution and compliance to applicable SOPS.

New Site/investigator Identification; Establish and Enhance Site Relationships
Identifies, evaluates and recommends potential investigators/sites on an on-going basis within assigned region for future clinical trial opportunities.
Initiates, develops and grows professional and collaborative relationships with Principal Investigators, all study personnel and necessary institution stakeholders
Align recommendations with MA, Clinical Operations and Clinical Development
Provide site due diligence assessments as required
Support development of Operational efficiencies at sites

On an as needed basis, Associate Director, regional site management may evaluate output from Trial Feasibility & Site Identification and provide feedback or due diligence on an identified site/center.

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

Education/Experience:

Bachelor's Degree in a Life Sciences field and a minimum of 7 of years' experience (3 years' experience with Masters; 2 years' experience with PhD or PharmD)
  • 3-5 years of advanced site monitoring/management in support of complex, oncology clinical trials across the development spectrum (Phases 1-3)
  • Knowledge of ICH/GCP and regulatory guidelines/directives
  • Understanding of industry trends (Risk Based Monitoring, Central Monitoring, etc.)
  • Ability to resolve a majority of complex study/site related issues independently using functional expertise while exercising excellent judgment and decision-making skills.

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 Director, Regional Site Engagement Manager

City
Basking Ridge

Functional Area
Global Clinical Operations & Planning

State
New Jersey