Job Opening for Sr. Clinical Operations Manager – Remote in CFT Consulting (Remote)

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Job Category : Management
Company Name: CFT Consulting
Position Name: Sr. Clinical Operations Manager – Remote
Location : Remote
Job Description : 6 Months Contract (Remote)Job DescriptionPosition Title: Senior Clinical Operations ManagerOBJECTIVES:Lead study operational strategy and planning and oversee execution of clinical studies for anassigned 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 qualitystandards (including ICH GCP, local regulations and Takeda SOPs), on schedule and onbudget. Oversee Strategic Partners and/or other CROs and other 3rd party vendors to meet Takeda’sobligations described in ICH-GCP and Takeda’s 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 thecoordination of multiple vendors, or other special assessments. More than one study and/or morethan one program may be assigned.ACCOUNTABILITIES: Accountable for planning and operational strategy and execution for assigned clinical trials.o Provides subject matter expertise and operational input into protocol synopsis, finalprotocol and other study related documents.o Challenges study team to ensure operational feasibility, inclusive of patient and siteburdeno Validates budget and ensures impacts are adequately addressed.o Participates in country and site feasibility/selection process, with a focus on providingcountry insights, corporate alignment and therapeutic expertise to ensure alignmentbetween study execution plan and program strategy.o Challenges study team to ensure timelines meet the needs of the clinical developmentplan.o Ensure new team members and vendors are appropriately onboarded.Job Descriptionv 02Aug20212 During Early Engagement with Strategic Partner(s) and/or other CROs, lead the developmentof the Operational Strategy in preparation for Operational Strategy Review; focus onensuring accurate assumptions are applied and robust risk management plans are in place. Provide oversight/support/guidance to Strategic partners/CRO to ensure study issues areaddressed and resolved rapidly. Responsible for study budget planning and management and accountable for external spendrelated 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 ClinicalOperations Program Lead(s); serve as escalation point for third party vendors managed byStrategic Partner and/or other CROs. Oversee Strategic Partners/CRO/vendor selection, budget and contract negotiation, andproper supervision of performance for all activities assigned to a StrategicPartner/CRO/vendor for assigned studies, including escalation of issues to governancecommittees 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 monitoringo Review and endorsement of relevant study plans, as applicableo Study team meeting management and attendance when necessary; regular review ofmeeting agendas and minuteso Review of outcomes/actions related to protocol deviations review; primary purpose ofreview is to support the identification of trends across sites and/or the studyo Documented review and monitoring of issues, risks and decisions at the study leveland implementation of appropriate mitigation strategies In partnership with data management, review and pressure test all database timelines andplans; 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 inspectionsby 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.EDUCATION, EXPERIENCE, KNOWLEDGE AND SKILLS:Education: Bachelor’s Degree or international equivalent required, Life Sciences preferred.Skills: Knowledge in global regulatory and compliance requirements for clinical research, includingbut not limited to US CFR, EU CTD, and ICH GCP. Awareness of local countryrequirements 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).Experience: 6+ years’ experience in pharmaceutical industry and/or clinical researchorganization, including 4+ years clinical study management/oversight. Experience must includeeither early phase clinical studies or Phase 2 and 3 studies and global/international studies orprograms. 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.TRAVEL REQUIREMENTS: Requires approximately 5-20 % travel, including overnight and international travel to otherTakeda sites, strategic partners, and therapeutic area required travel.Job Types: Full-time, ContractSalary: $150.00 – $160.00 per hourSchedule:8 hour shiftEducation:Bachelor’s (Preferred)Work Location: Remote
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