Finance Analyst
4 days ago
The Director / Senior Director of Clinical Operations is responsible for the oversight of clinical teams and processes within the Clinical and Regulatory Operations business unit. Additionally, is a lead for strategic planning and implementation of processimprovement in support of operational excellence aligned with project/programme delivery, the clinical/regulatory operations business unit and the CRO enterprise. The incumbent has oversight and management responsibility for personnel within the departmentto include but not limited to: Clinical Team Leads, Clinical Research Associates or other clinically focused roles within the Clinical and Regulatory department. Responsible for representing Cmed Clinical and Regulatory Operations externally to current andprospective clients; providing leadership support to business development activities such as participating in capabilities presentations, bid defence meetings, and working with contracts and proposals service function to develop quality proposals. Supportrecruitment, supervision and development of staff as well as ensure available resources are balanced with contracted obligations and corporate objectives. Principal Responsibilities:StrategicWorks with global functional leaders and external partnerships tosupport and drive clinical processes and task delivery.Serves as senior leader within Cmed operations matrix structure in support of global organizational needs and assist in the evolution of a global structure as the company grows.Lead process improvementinitiatives across operational unit and in alignment with the CRO to deliver efficiencies and benefits to customers.Support Cmed's launch of innovative solutions through the implementation of change management programming to ensure adoption and sales for continuedgrowth.Ensure compliance with regulations and industry quality standards and assurance of audit readiness; includes the development of suitable company SOPs and compliance with FDA, EMEA, country specific and ICH-GCP guidelines and representation during auditsand inspections.Leadership and Operational Management Effectively communicate critical updates and changes within industry guidance, trends, and department performance on a regular basis, acknowledge employee/project successes and address risks to deliverywith a focus upon mitigation planning.Review and identify industry and CRO performance trends and proactively respond to drive solution-based discussions and outcomesLead and support the development of early risk identification which pose obstacles to thesuccessful delivery of programme/project outcomes. Project ManagementServe as a key contact for assigned programmes/projects.Responsible for the management of third-party vendors working in association with assigned programs and projectsLead team in the deliveryof contracted services.Execute project oversight ensuring adherence to company SOPs, FDA, and ICH guidelinesInteract with other departments to ensure high quality and execution of deliverables on-time and within budget.Review project budgets, monitoring costs,potential overruns, and implement cost effective solutions.Provide regular project reports and updates to customers, as requested.Use effective communication skills and effective working relationships to ensure consistent quality of work. Global Resourcingand Line ManagementResponsible for compensation planning and talent review for direct reports.Proactively participate in the selection and recruitment of suitable and qualified staff.Proactively assess, revise, and improve training processes and requirementsto meet changing needs.Support/conduct performance appraisals; coach and develop staff for further advancement or enhanced skill development.Provide guidance and mentoring to direct reports.Customer Partnerships and DeliveryEstablish and maintain strong workingrelationships with clients, vendors, and company staff.Serve as point of escalation for customer accounts.Take a lead in the business development of clinical and regulatory services through proposal writing, strategy alignment and coaching staff in bid defencepractices. AdditionalThe above job description in no way states or implies these duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.TheCompany reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and Company. Essential Work Experience, Qualifications and Knowledge:Bachelor's or Master's degree in life sciences,or equivalentMinimum of 10 years global drug development experience with deep clinical research and functional experience in the Pharmaceutical/Biotech and CRO industriesKnowledge of ICH GCP guidelines and industry standards of qualityProblem solving capabilitieswith strong attention to detailRelationship building skills and strong interpersonal presenceDesirable Work Experience, Qualifications and Knowledge:Clinical research experience in numerous therapeutic and/or functional areasProven functional and change managementexperience within the Pharmaceutical/Biotech and CROindustryAbility to prioritise multiple tasks and follow to completion with industry expertiseStrong motivational skills and understanding of customer serviceWhat we offer:A dynamic, friendly and supportiveteamInnovative and exciting technologies encapsia® and insights®Mentorship and training to further develop your skillsWell-designed induction/onboarding programCompetitive compensation package Home or office-based location
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