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SUMMARY: Accountable for site activation project management and delivery activities within the assigned therapeutic area. Responsibilities include coordination, collaboration and oversight of site identification and central and local ECs (for NA countries only) activities, progression of essential documents collection, monitoring of investigator and site contracts status, and any other country and/or study specific site activation tasks necessary for Site Activation in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). May also include pre award support by providing site activation related input into the proposal text and budget items. Reports to a senior member of the Site Activation leadership team within the assigned therapeutic area.RESPONSIBILITIES:*_Tasks may include but are not limited to: _Serve as the primary point of communication and accountability for study start-up and maintenance (if applicable) activities on assigned projectsOversee project activities of functional groups involved in site activation to ensure critical path activities are completed on-time and within budgetEnsure accurate compilation, management, tracking and analysis of site activation activities in a timely mannerMay support feasibility and/or site identification activities, as neededWork closely with assigned team members to expedite the Site Qualification and Selection processEffectively communicate Site Activation & Regulatory (if applicable) project status to the Sponsor, GPL/CPM and project teamPrepare risk assessment and mitigation plans relating to project deliverables with input from other rolesResponsible that relevant study activities are present in the work order budget. Ensure OOS activities are tracked and captured within Change Notification Form (CNF) and follow through to execution of change orderWork in conjunction with assigned project team members to develop and maintain site activation related project plansMay contribute to the development, review, and maintenance of SOPs and best practice guidelines and provide training/coaching pertaining to activities of the Site Activation departmentProvide input to departmental process improvement initiativesEstablish and interpret site activation metrics to help drive corrective action for achieving deliverables, milestones and/or KPIsMay participate in business development activities by contributing to proposals and bid defense meetings by preparing relevant sections of proposals, budgets and other country and/or study specific activities related to Site ActivationReport and/or escalate issues to Line Manager, Site Activation Portfolio Lead and/or Site Activation Therapeutic Lead to ensure resolution and minimize risks to on-time deliverablesComply with SOPs, ICH GCP and national regulations as applicableLiaise with other functional contributors and vendors as neededPerform other duties as assigned The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.*OTHER SKILLS AND ABILITIES: *Strong leadership and organizational management skills in planning, strategizing, managing, monitoring, scheduling, and critiquingAbility to exercise sound judgment and make decisions independently and to proactively identify and solve problemsAbility to provide experience and input into initiatives relating to interacting with sites and/or customersAbility to motivate, lead and engage a teamStrong interpersonal skills in a fast-paced, deadline oriented, and changing environmentStrong oral and written communication skills to clearly and concisely present informationDemonstrated ability to collaborate across the businessTeam-oriented work style; seeks and gives guidanceUnderstanding of regulatory processes and guidelinesUnderstanding of initiation, planning, and execution of clinical projects and overall project planningAwareness of ICH GCP Guidelines and the FDA/EU Clinical Trials Directives/National regulations (CTAs, Amendments, Urgent Safety Measures, End of Trial Notifications)Ability to handle multiple tasks in a fast-paced and constantly changing environmentAbility to work in an organized, methodical, and self-motivated mannerProficiency in MS-Office applications including Microsoft Word, Excel, and PowerPoint; digital systems aptitude*REQUIREMENTS: *A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related science OR two-year college curriculum or equivalent education / training (nursing degree or equivalent life science degree) and experience within clinical research (e.g. CRA, Reg Affairs)Minimum of 4 years CRO/pharmaceutical industry experience, preferably in Start-up Management, Project Management, and/or Site Management experienceProficient in cross-cultural communicationProficient in both spoken and written EnglishPromotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently. We love knowing that someone is going to have a better life because of the work we do.
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Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law .