Senior Manager, Clinical Operations Program Lead
Company: Integrated Resources
Location: Somerville
Posted on: June 17, 2022
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Job Description:
Job Description
*This role requires full vaccination aProductst COVID-19 as a
condition of assignment, subject to a valid and approved medical or
religious accommodation*
Position Title: Senior Manager, Clinical Operations Program Lead
(COPL)
Function: Global Development Office
Department: Global Clinical Operations
Reports To (Position Title): Senior Director or Director, Clinical
Operations
OBJECTIVES:
Provide operational expertise and strategic input to the
development of Clinical Development Plans (CDP) supporting the
overall clinical strategy for one or more clinical programs.
Develop and lead the program-level operational strategy and
planning on assigned programs in close collaboration with our
strategic partners and other vendors.
Provide program-level sponsors operational oversight of our
strategic partners and other vendors to ensure the effective
execution of the clinical studies on time, with high quality and
within agreed budget.
Represent Clinical Operations at the Global Program Team (GPT) and
partner with Global Clinical Lead to lead the Clinical Sub Team
(CST) accountable for the development and execution of the CDP.
ACCOUNTABILITIES:
Accountable to the GPT for the translation of the CDP into an
optimal operational strategy and plan. Ensures assessment of
various operational scenarios for optimal execution of the CDP.
Partners with the CST to develop high quality study
synopsis/protocol by providing operational input and by ensuring
all relevant stakeholders (both internal and external) are involved
and contributing.
Collaborate with early or late phase COPL counterpart to ensure
alignment and seamless interactions with the GPT.
Maintain close communication with the Global Program Leader to
ensure expectations and activities are aligned.
Develop and lead the early or late phase clinical program
operational strategy and planning on assigned clinical programs in
close collaboration with the Clinical Operations Managers (COMs),
our strategic partners/other CROs, other vendors, and with the
CST.
Perform program-level oversight of our strategic partners and other
vendors to ensure the overall operational execution and delivery of
the assigned clinical programs in compliance with quality standards
(including ICH GCP, local regulations and SOPs), on schedule and on
budget.
Collaborate with COMs and cross-functional counterparts to oversee
the performance for all activities assigned to our strategic
partners/other CROs/other vendors, including escalation of issues
to governance committees and to senior management when
warranted.
Responsible for clinical program budget planning and accountable
for external spend related to clinical program execution. Works
closely with COMs, Global Program Management (GPM), Outsourcing
Management, and Finance to ensure on a regular basis that budgets,
enrolment, and gaiting are accurate.
Communicates program status, cost and issues to ensure timely
decision-making by senior management.
Provide program-level direction, guidance and support to the COM in
development of study strategy operational plans including enrolment
models and risk management strategy.
Serve as the point of escalation for the COMs for issues that cant
be resolved at the study level.
May participate in Business Development/in-licensing/alliances
evaluations by providing operational due diligence.
Review and provide expert clinical operations input into clinical
documents related to the drug development process including
Investigator Brochures, Investigational New Drug Applications
(INDs) and/or Investigational Medicinal Product Dossier (IMPDs),
study synopsis & protocols, clinical study reports, applicable
sections of the New Drug Application (NDA) and/or Marketing
Authorization Application (MAA), updates to IND and NDA documents,
DSURs and other safety reports; Provide expert clinical operations
input into preparation for key regulatory meetings (e.g.
End-of-Phase 2, Request for Scientific Advice Meetings, etc.), as
appropriate.
Collaborate with COMs, Strategic Partners/other CROs/other vendors
to ensure inspection readiness.
Leads Clinical Operations aspects of inspection readiness
activities, and acts as subject matter expert during regulatory
inspections
Contribute to functional strategic initiatives and process
improvement.
Actively seek new ways of working more efficiently to meet the
needs of clinical development.
Act as a role model for values.
For certain types of studies and programs, COPL may have the
following responsibilities:
o Is a key point of contact between the strategic
partners/preferred supplies and the GPT/CST.
o Provide program & study-level direction and support to the
strategic partners/preferred suppliers for the development of study
strategy operational plans including enrolment models and risk
management strategy.
o Performs site feasibility/capability assessments for
programs/studies requiring specialized experimental tests and/or
technologies and work with internal experts and sites to ensure
successful operational outcomes
o Work with Procurement, QA & Legal to qualify new clinical vendors
and, when appropriate, manage vendors for duration of a study (for
vendors contracted directly with )
Product OF SUPERVISION:
NUMBER SUPERVISED WORKERS Direct Indirect
Employees 0 0
Non-Employees 0 0
EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:
Education:
Bachelors Degree or international equivalent required, Life
Sciences preferred.
Skills:
Demonstrated excellence in project/program management, including
scenario assessment, risk assessment and contingency planning
Demonstrated excellent matrix leadership and communication
skills
Able to influence without authority
Excellent teamwork, communication, organizational, interpersonal,
conflict resolution and problem-solving skills
Entrepreneurial and innovative; takes measured risks; thinks
outside the box; challenge the status quo
Pragmatic and willing to drive and support change
Is comfortable with ambiguity
Embody a culture of continual improvement and innovation; promote
knowledge sharing
Fluent business English (oral and written)
Experience:
8+ years experience in pharmaceutical industry and/or clinical
research organization, including 5+ years clinical study/project
management/oversight. Experience must include early phase clinical
studies/Phase 2 studies or later phase global/international studies
or programs. Experience in more than one therapeutic area is highly
desired.
Expertise in global regulatory and compliance requirements for
clinical research, including but not limited to US CFR, EU CTD, and
ICH GCP. Awareness of local country requirements is also
required.
Advanced degree(s) (e.g., Master or Doctorate) and relevant
training or experience (e.g., fellowship. internships, etc.) may be
considered to supplement experience requirements.
TRAVEL REQUIREMENTS:
o Requires approximately 5-20 % travel, including overnight and
international travel to other sites, strategic partners, and
therapeutic area required travel.Job SnapshotEmployee
Type:InternLocation:Cambridge, MAJob Type:Health CareExperience:Not
SpecifiedDate Posted:5/23/2022
Keywords: Integrated Resources, Somerville , Senior Manager, Clinical Operations Program Lead, Executive , Somerville, Massachusetts
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