Website Lenox Executive Search
Lenox Executive Search is seeking an experienced Sr. Clinical Operations Manager, to fill a 6+ month (Temp to Perm) onsite contractual role, with a leading global pharmaceutical company in Cambridge, MA
Lead study operational strategy and planning and oversee execution of clinical studies for an
assigned clinical program(s), supporting clinical strategy defined in Clinical Development Plan.
In close collaboration with Clinical Operations Program Lead(s):
· Oversee the execution of studies in assigned clinical program(s) in compliance with quality
standards (including ICH GCP, local regulations and internal SOPs), on schedule and on
· Oversee Strategic Partners and/or other CROs and other 3rd party vendors to meet company
obligations described in ICH-GCP and business objectives.
The assigned clinical studies may be high complexity and/or high risk, e.g. multiple indications,
data safety monitoring boards and/or endpoint review committees, interim analyses, requiring the
coordination of multiple vendors, or other special assessments. More than one study and/or more
than one program may be assigned.
· Accountable for planning and operational strategy and execution for assigned clinical trials.
o Provides subject matter expertise and operational input into protocol synopsis, final
protocol and other study related documents.
o Challenges study team to ensure operational feasibility, inclusive of patient and site
o Validates budget and ensures impacts are adequately addressed.
o Participates in country and site feasibility/selection process, with a focus on providing
country insights, corporate alignment and therapeutic expertise to ensure alignment
between study execution plan and program strategy.
o Challenges study team to ensure timelines meet the needs of the clinical development
o Ensure new team members and vendors are appropriately onboarded.
· During Early Engagement with Strategic Partner(s) and/or other CROs, lead the development
of the Operational Strategy in preparation for Operational Strategy Review; focus on
ensuring accurate assumptions are applied and robust risk management plans are in place.
· Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues are
addressed and resolved rapidly.
· Responsible for study budget planning and management and accountable for external spend
related to study execution. Works closely with Clinical Operations Program Leader(s),
Global Program Management, and Finance to ensure on a regular basis that budgets,
enrollment, and gaiting are accurate; Communicates study status, cost and issues to Clinical
Operations Program Lead(s); serve as escalation point for third party vendors managed by
Strategic Partner and/or other CROs.
· Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, and
proper supervision of performance for all activities assigned to a Strategic
Partner/CRO/vendor for assigned studies, including escalation of issues to governance
committees when warranted.
· Specific areas of sponsor oversight include, but are not limited to:
o Review and approval of key monitoring documents/plans, periodic review of outputs,
decisions and actions related to monitoring
o Review and endorsement of relevant study plans, as applicable
o Study team meeting management and attendance when necessary; regular review of
meeting agendas and minutes
o Review of outcomes/actions related to protocol deviations review; primary purpose of
review is to support the identification of trends across sites and/or the study
o Documented review and monitoring of issues, risks and decisions at the study level
and implementation of appropriate mitigation strategies
· In partnership with data management, review and pressure test all database timelines and
plans; ensure strong linkage between the strategy (i.e., filing/registration, data generation,
etc.) with the tactical plan for database lock and CSR.
· Ensure studies are “inspection ready” at all time; may be involved in regulatory inspections
by preparing for and/or attending the inspections.
· Represent the Clinical Operations Manager role in functional initiatives or working groups.
· Help with onboarding and mentoring of new or junior COMs.
· May assist the program COPL in his/her role, as required.
Bachelor’s Degree or international equivalent required, Life Sciences preferred.
· Knowledge 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.
· Demonstrated excellence in project/program management and matrix leadership.
· Excellent communication skills.
· Excellent teamwork, organizational, interpersonal, and problem-solving skills.
· Fluent business English (oral and written).
6+ years’ experience in pharmaceutical industry and/or clinical research
organization, including 4+ years clinical study management/oversight. Experience must include
either early phase clinical studies or Phase 2 and 3 studies and global/international studies or
programs. Experience in more than one therapeutic area is advantageous.
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.
· Requires approximately 5-20 % travel, including overnight and international travel to other
company sites, strategic partners, and therapeutic area required travel.