Messages In This Digest (2 Messages)
- 1.
- Outsourcing Manager, Clinical Contracting Excellence - East Hanover From: Keith Bogen SPHR
Messages
- 1.
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Outsourcing Manager, Clinical Contracting Excellence - East Hanover
Posted by: "Keith Bogen SPHR" keith.bogen@yahoo.com hrslugger2002
Fri Jul 22, 2011 9:27 am (PDT)
My name is Gina Brigante and I'm a recruiter with Kaztronix. We came across
your resume in our database and feel that you could be qualified for one of our
positions with a Global Pharmaceutical Company. The job description is posted
below for your review. If you are interested, please respond with an updated
copy of your resume in MS Word format.
Phone calls and faxes will not be accepted, all interested candidates must apply
on-line at www.kaztronix.comor simply reply to this email with an updated copy
of your resume. Otherwise, should your qualifications meet the requirements of
a position with Kaztronix, a recruiter will be in contact with you.
If this position does not match your background and skills, we would like to
keep you in mind for future openings. However, if you happen to know someone
who may be qualified or interested, we have a great referral bonus program.
Job Title: Outsourcing Manager, Clinical Contracting Excellence
Location: East Hanover, NJ
Job Description:
Job Title: Outsourcing , Clinical Contracting Excellence
Job Category: Clinical and Scientific
Duties:
Direct the utilization of Contract Research Organizations (CROs), Central Labs.
and Specialty Providers to assure the delivery of quality, timely and
cost-effective external resources to support the Development pipeline. Lead
projects, working groups, initiatives to ensure Clinical Contracting Excellence
(CCE) is prepared to successfully respond to the changing needs & requirements -
legal, operational, regulatory & financial - of our internal & external
customers, worldwide.
Lead the selection of the optimum External Service Provider (ESP) {CRO, Central/
Reference Lab, and Specialty provider} at both the tactical and strategic level
based on fit for purpose, or value added services, cost avoidance and savings
opportunities..
Train Clinical Teams in outsourcing procedures, assist Clinical Teams in
defining the scope of work, and in some cases define the scope of work for both
original contract and contract amendments.
Negotiate contract terms, scope of work, pricing and payment schedules, ensuring
that the agreements with the ESPs are commercially advantageous to ` `, while
minimizing regulatory, legal, and financial risks through close collaboration
with functional partner such as legal, Finance, QA, and functional lines
Produce final contracts/amendments and secure all necessary company approvals
including SOX compliance to facilitate execution of said agreements
Manage ongoing ESP collaborations (business conflicts, issue resolution, project
status, adherence to budget)
Manage the interface between CCE, internal key stakeholders and where
appropriate ESPs to enhance the success of outsourced trials
Contribute to Protocol Design Meetings and Clinical Devemopment Plans, when and
where applicable
Support the MSA(s) language and rates negotiations for Strategic and
non-Preferred ESPs
Contribute to vendor audit requests and facilitate corrective action plans
following a CQA audit of non-preferred ESP.
Ensure ESPs are delivering in line with expectations.
Lead and manage initiatives related to departmental objectives. Participate in
initiatives related to Global Development objectives
Help coach and mentor new associates
Skills:
At least 8 years experience in Drug Development in Pharmaceutical Industry or
with a Central Laboratory
Detailed understanding of the clinical development process and very robust
understanding of the management of clinical trials
Demonstrated ability of completing projects on time and within budget.
Excellent influencing and negotiation skills.
Solid understanding of contracts (including solid legal understanding of terms
and conditions).
Familiar with the CRO/Central Laboratories/Reference Laboratories and Specialty
Provider marketplace.
Solid financial understanding (understanding of cost drivers for clinical
trials) as it relates to contracts and cost reductions.
Excellent written and oral communications skills.
Strong problem solving skills.
Ability to think strategically and to visualize potential future scenarios based
on business needs
Demonstrated willingness to make decisions and to take responsibility for such.
Ability to address issues assertively while maintaining a non-threatening
posture
Excellent interpersonal skills (team player).
Fluent English – Oral and written
Education:
Bachelor's Degree / PhD, MBA or equivalent desirable.
Hrs Per dy: 7.50
Hrs Per Week: 37.50
Best Regards,
Gina Brigante
Kaztronix, LLC
33 Wood Avenue South 1st FloorIselinNJ08830
(888) 525-7073
Email: gbrigante@kaztronix.com
- 2a.
-
OLM N2N Employment Network: Schedule and Open Business Networking
Posted by: "Bob" bob_longo1@yahoo.com bob_longo1
Fri Jul 22, 2011 7:13 pm (PDT)
OLM N2N Employment Network: Schedule and Open Business Networking
**Please pass this on to anyone who is "networking" minded**
7/27/11 *VACATION* * NO MEETING*
8/3/11 *VACATION* * NO MEETING*
8/10/11 Interview preparation personal presentation -- Carolyn E. Scott, MA
8/17/11 BUSINESS NETWORKING -- Everyone is welcome
This is a (no cost) opportunity to build local connections.
**Please bring your friends**
8/24/11 "Working the Room". -- Marty Latman
8/31/11 "Finding Your Hidden Keys" -- Rich Matrisciano
--------------------- --------- --------- --------- -----
We meet every Wednesday at 7:00 PM
Our Lady of the Mount church
167 Mount Bethel Road
Warren, NJ 07059
(908) 647-1075
www.olmwarren.org
--------------------- --------- --------- --------- -----
- Join us and tell your friends
- We are open to anyone; employed, unemployed, under-employed or those willing to help
- Our aim is to mentor job seekers and match them with employers
- Come strengthen your individual network
--------------------- --------- --------- --------- -----
Directions to the Church from Route 22
* Take Route 22 to Warrenville Road
* Coming FROM THE EAST, turn RIGHT onto Warrenville Road
* Coming FROM THE WEST, turn take the jug-handle LEFT onto Warrenville Road
* Go about 3 miles, you will pass through the center of Warren
* Watch for "Scarpellinos", a house-restaurant on your right with a white picket fence
* The next turn on your right leads you into the CHURCH parking lot
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