Sr Country Site Activation Lead in Brazil

Job Overview Direct and manage the delivery of allrequired site activation, maintenance and regulatory activities forselected studies or multi-protocol programs, including pre-awardactivities, oversight of the scope of work, budget and resources.

Lead (sub)-regional and / or functional strategic initiatives andwork with senior management across disciplines to developimplementation plans.

Seasoned professional individual contributorwho works under minimum supervision. May mentor or otherwise helpnewer team members navigate processes.

Responsible for makingadjustments or recommended enhancements in systems and processes tosolve problems or improve effectiveness of job area - and supportdocumentation of lessons learned, success stories and performancemetrics.

Problems faced are predominantly routine thoughoccasionally non-routine and are generally resolved with minimalmanagement oversight and guidance. Essential Functions

• Overseethe execution of Feasibility, Site ID, Site Activation (includingpre-award / bid defense activities) and / or Maintenance for assignedprojects in accordance with the agreed RSU site activationstrategy, adhering to project timelines.
• Develop, implement andmaintain the Management Plan according to the Scope of Work andProject Plan, within the agreed project strategy, resolvingproject-related issues where required.
• Ensure collaborationacross Feasibility, Site ID, Regulatory & Site Activation,including communication with regions and countries, to successfullydeliver the agreed project scope in compliance with the RSUManagement Plan.
• Create and / or review technical andadministrative documentation to support business development andenable study initiation and maintenance, as required.
• Providespecialist functional and technical scientific support tofacilitate efficient business development, initiation andmaintenance of clinical trials, whilst enabling compliance withfunctional / regulatory requirements.
• Provide overall guidance andoversight of multi-regional and multi-protocol programs duringinitial start-up and maintenance phase as an integral member of thestudy management team.

Determine regulatory strategy / expectationsand parameters for submissions and all necessary authorizations.

• Identify functional / regulatory complexity and challenges and offercreative and practical solutions to support the bid process andsubsequent execution of the site activation plan.
• Assess andreview the functional / regulatory landscape and contribute to thecollection, interpretation, analysis and dissemination of accurateregulatory intelligence to support assigned studies and widercompany, as required.
• Execute operational strategy / expectationsfor maintenance of clinical study approvals, authorizations andreview / negotiation of contracts and essential documents.
• Workwith Quality Management to ensure appropriate quality standards forthe duration of site activation (or Maintenance, as applicable).
• Mentor and coach colleagues as required.
• Ensure accuratecompletion and maintenance of internal systems (with emphasis onCTMS), databases, tracking tools, timelines and project plans withproject-specific information.
• May take a lead role in developinglong-standing relationships with preferred IQVIA customers. Deliverpresentations / training to clients, colleagues and professionalbodies, as required.
• May be involved in activities related tomonthly study budget planning and reviews.
• Assume appropriateownership for strategic initiatives within assigned unit ofaccountability including recommendation of measures for success.
• Provide support to ensure service offerings meet or exceed customerexpectations.
• Collaborate with management and other functionalleadership to support improved efficiencies, project outcomes andquality metrics for Feasibility, Site ID and Site Activationprojects. Qualifications
• Bachelor's Degree in a lifescience-related discipline.
• 7 years’ relevant experience in ascientific or clinical environment including demonstrableexperience in an international role.
• Experience with siterelationship, site identification, and clinical protocol.
• Thorough understanding of regulated clinical trial environment andknowledge of drug development process.
• Advanced level of English.#J-18808-Ljbffr