1 Message
Digest #3446
Message
Thu Feb 11, 2016 1:54 pm (PST) . Posted by:
"David Pearlstein" dlpconsultingnj
If interested, please respond directly to the recruiter (not me).
Good luck,
David
https://www.linkedin.com/in/dpearlstein
From: Rachel Saager [mailto:
Sent: Thursday, February 11, 2016 3:48 PM
To: David Pearlstein
Subject: MDO Protocol Manager job opening - David
Hi David,
I came across your resume and would like to know if you were currently on
the market? I have a great position opened with a pharmaceutical company in
your area. Please take a look at the job description and if you are
interested you can email me at RSaager@GreenKeyLLC.com
JOB DETAILS
Job Title: MDO Protocol Manager
Company: Green Key Resources
Ultra#: 133654
Client: BMS
Start Date: ASAP
Job Title: MDO Protocol Manager
City/State: Plainsboro, NJ
Zip Code: 08536
Assignment Duration: 6 months renewable
Position: PROTOCOL MANAGER, World Wide Medical Data Operations (MDO)
Description: A World Wide Medical Data Operations Protocol Manager will
provide end-to-end management of Non-Regulatory Data Generation (NRDG)
clinical research. They will provide expertise in a disease area (oncology
or speciality), and will focus on studies including late stage
interventional research and expanded access programs (EAP) & other study
types. Protocol managers act as a matrix leader for the Study Management
Team and are accountable for the timely execution of NRDG.
Requirements:
. Manages complex and varied study types across a matrix organization.
. Uses clinical trial management systems to track metrics, timelines, and
other data to assure Protocol and/or Program quality, timelines and budget
are managed according to expectations.
. Facilitates identification and prompt escalation of project risks and
issues along with mitigation / resolution strategies to appropriate
stakeholders and/or functional management, to expedite resolution.
Proactively analyzes and drives efficient problem solving within team's
control. Applies critical thinking to manage complex issues. Effectively
leads team in collating information for operational reviews, highlighting
issues and risks, developing mitigation and resolution strategies, and
promptly responding to action items.
. Manages clinical components of vendor selection and acts as a central
point of contact for communication between the team and the external
partners (e.g., CRO, networks, alliance partners etc.). Allows vendors
autonomy in managing their assignments, while holding them accountable for
deliverables. Ensures that tasks assigned to vendors are not duplicated by
internal protocol/program team members.
. Builds strong relationships and encourages collaboration with team members
and internal and external stakeholders across organizational, functional,
and geographic boundaries to achieve project and/or program deliverables.
Creates synergy with stakeholders and develops strong alliances with the
Medical Monitor/Study Director, Operations Lead, and other team members.
Effectively leverages network of internal and external contacts.
. Strong understanding of the pharmaceutical industry and of the
non-clinical, clinical, business, ethical and regulatory components in the
global drug development process. Strong understanding of GCPs, ICH and
regulatory guidelines as they apply to protocol management and program
strategy.
. Understands the influences of safety and efficacy profiles, labeling,
legislation and marketing on the life cycle of a compound.
. Minimum education BA/BS.
. Prefer individual with strong science background with a minimum of 5 years
of demonstrated complex trial management experience in the pharmaceutical or
CRO industry.
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