Senior Manager, Clinical Outsourcing
Company: Sun Pharmaceutical Industries, Inc.
Location: Princeton
Posted on: October 30, 2024
Job Description:
-Title: Senior Manager, Clinical Outsourcing -Sun Pharma is the
world's fourth largest specialty generics company with presence in
Specialty, Generics and Consumer Healthcare products. Supported by
more than 40 manufacturing facilities, we provide high-quality
medicines, trusted by healthcare professionals and patients, to
more than 100 countries across the globe. Over the last two
decades, Sun Pharma has established itself as a leading player in
the generics market in the U.S., and we are rapidly ramping up our
presence in the specialty branded market with a focus on
dermatology, ophthalmology and onco-dermatology. - -Description:
-Sun is seeking a Senior Manager, Clinical Outsourcing within its
Clinical Outsourcing Team in Princeton, NJ. - The Senior Manager,
Clinical Outsourcing will report into Sr. Director, Clinical
Outsourcing. - Under the direction of the Senior Director, Clinical
Outsourcing, the Senior Manager, Clinical Outsourcing will lead and
manage the clinical trial outsourcing, vendor selection and
contract negotiation, vendor management, and reporting process for
Sun Pharmaceutical's clinical development programs. - This role
will be Instrumental in the management of external partnership
outcomes for clinical trials, including coordination and management
of service providers and other outsourcing needs. Responsibilities
include clinical CRO/vendor identification, RFI/RFP development and
execution, vendor selection, contract negotiations, budget
management and service provider performance metrics development and
tracking. - - -Responsibilities: -35% Vendor selection and contract
negotiation:
Guides project teams through the
outsourcing process and gives appropriate suggestions and advice on
the best approach / best practices Guides and participates in the
evaluation, selection, and negotiation of contracts for assigned
studies/programs.Works with Project Managers and Project Teams to
develop RFPs.Works with Project Managers and Project Teams for all
operational, scheduling, project budget and cost-saving
considerations for assigned studies/programs.Liaises with project
teams to develop the Statement of Work (SOW) for each contract;
coordinates the SOW review and finalization process.Negotiates new
and amended work specifications, budgets, payment schedules,
relationship management plans, and other documents that control the
activities and performance of contract service providers. -25%
Vendor management: 15 - 25 Vendor per study
Participates in scheduling,
organizing, and facilitating kickoff meetings with
vendors.Participates team meetings with vendors.Supports the
project teams to assure the quality and timeliness of deliverables
through outsourcing.Monitors and manages relationships with
contracted vendors; facilitates the resolution of issues and
conflicts.Supports organizational governance activities with
vendors.Works with Project Teams to ensure outsourced clinical
trial activities meet quality standards and expectations and
adheres to applicable Corporate SOPs, WPs, policies, guidelines,
and regulations.Ensures smooth and effective communication between
the vendors and the company.Ensures Vendors/CROs are accountable
and Identifies issues and develop solutionsFacilitates the closure
of each study/contract with the vendor, including a mutual
assessment of performance. -30% Support Outsourcing Team
- Locate Statement of Work (SOW) for
each study level agreement; save the working documents as well as
final contracts to the Clinical Outsourcing folder.Ensure
consistent naming conventionReview CRO Contract & populate category
spend to allow for analysisAbility to Liaise with project teams,
CROs and VendorsAbility to search Contract Management SystemCreate
Vendor Contract Trackers for each study and update with contract
data and termsCollect and analyze data from CRO contracts Setup
Outsourcing Onboarding guidelines.Support the development of
templates and save to Outsourcing folders.Setup cost-saving excel
file.Assist with creating clinical trial budgeting models and
what-if scenarios for future trials
- Assist with FP&A needs related to clinical vendors,
including annual budgeting, periodic forecasting, and monthly
budget vs. actual analysis -10% Cross-Functional Support
Assist with creating clinical trial
budgeting models and what-if scenarios for future trialsAssist with
FP&A needs related to clinical vendors, including annual
budgeting, periodic forecasting , and monthly budget vs. actual
analysis -
- Core technical skills
- Demonstrated expertise in forecasting, budgeting, data
analytics, modeling, and process improvement design.
- Pharmaceutical portfolio experience across teams, collaborating
with Clinical Operations, Cost Management, Finance and Procurement
functions
- Vendor and or clinical CRO oversight experience, ensuring
execution within budget, on time, and of the highest quality
- Must have extensive experience managing CROs, central
laboratories, and other clinical study vendors, including trial
sites
- Positive management style, combined with superior communication
skills and unwavering ethics and integrity
- Strong interpersonal skills with demonstrated ability to
connect, collaborate and build relationships across all levels and
functions and establish credibility with leaders and key external
stakeholders
- Strong oral and written communication skills with ability to
communicate effectively at all levels and present complex and/or
new ideas both internally and with external stakeholders
- Extensive knowledge of GCP and ICH principles of clinical trial
conduct
- Strong computer skills with demonstrated experience in working
with the Microsoft suite of programs (Word, Excel, PowerPoint, and
Outlook). Microsoft Project a plus. -
- Core leadership behavioral skills/ leadership skills
- Leadership Skills: Strong leadership and team management
skills, with a track record of effectively leading cross-functional
teams.
- Strategic Thinking:
- Analytical Skills:
- Problem-Solving: Strong problem-solving and decision-making
capabilities, with the ability to navigate complex challenges.
- Industry Awareness: Stay current with industry trends, emerging
therapies, and advancements in clinical trial methodologies.
- Interpersonal Skills: Collaborative and able to build strong
relationships with internal teams and external partners.
- Contributes to a team culture that promotes continuous
improvement, ownership, professional growth, and inclusion.
-Qualifications: -
- BA or MS in relevant discipline
- Minimum of 5 years clinical outsourcing experience - - -The
presently-anticipated base compensation pay range for this position
is $ to $ . Actual base compensation may vary based on a number of
factors, including but not limited to geographical location and
experience. In addition, this position is part of the Annual
Performance Bonus Plan, and is be eligible for a company vehicle
and incentive bonus compensation. Employees are eligible to
participate in Company employee benefit programs which include
medical, dental and vision coverage; life insurance; disability
insurance; 401(k) savings plan; flexible spending accounts; and the
employee assistance program. Employees also receive various paid
time off benefits, including vacation time and sick time. -The
compensation and benefits described above are subject to the terms
and conditions of any governing plans, policies, practices,
agreements, or other materials or documents as in effect from time
to time, including but not limited to terms and conditions
regarding eligibility. -If hired, employee will be in an "at-will
position" and the Company reserves the right to modify base salary
(as well as any other discretionary payment or compensation
program) at any time, including for reasons related to individual
performance, Company, or individual department/team performance,
and market factors. -The preceding job description has been
designed to indicate the general nature and level of work performed
by employees within this classification. It is not designed to
contain or be interpreted as a comprehensive inventory of all
duties, responsibilities and qualifications required of employees
as assigned to this job. Nothing herein shall preclude the employer
from changing these duties from time to time and assigning
comparable duties or other duties commensurate with the experience
and background of the incumbent(s). -We provide equal employment
opportunities for all current employees and applicants for
employment. This policy means that no one will be discriminated
against because of race, religion, creed, color, national origin,
nationality, citizenship, ancestry, sex, age, marital status,
physical or mental disability, affectional or sexual orientation,
military or veteran status, generic predisposing characteristics or
any other basis prohibited by law. -Notice to Agency and Search
Firm Representatives:Sun Pharmaceuticals (Sun) is not accepting
unsolicited resumes from agencies and/or search firms for this job
posting. Resumes submitted to any Taro employee by a third party
agency and/or search firm without a valid written & signed search
agreement, will become the sole property of Taro. No fee will be
paid if a candidate is hired for this position as a result of an
unsolicited agency or search firm referral. - - - - - - -
Keywords: Sun Pharmaceutical Industries, Inc., Westport , Senior Manager, Clinical Outsourcing, Healthcare , Princeton, Connecticut
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