The World Leader In Serving Science
Global Study Director
Location
Italy + 5 moreAll locations: Italy | Romania | Serbia | Bulgaria | Netherlands | Poland
Posted
92 days ago
Salary
0
Seniority
Lead
No structured requirement data.
Job Description
Global Study Director
Thermo Fisher Scientific
Title: Global Study Director - FSP - EMEA - Remote, Milano, Italy - Remote, Romania - Remote, Serbia - Remote, Bulgaria - Remote, Poland - Remote, Netherlands Full time Remote Join Us as an Global Study Director - Make an Impact at the Forefront of Innovation The Global Study Director (GSD) is a business-critical role within Cell Therapy Clinical Operations (CTCO) whose main accountability is the operational planning and delivery of high priority and complex clinical studies within a program, that are deemed most critical to the business. The GSD is responsible for leading a cross-functional study team (core and extended) and for providing the team with direction and guidance to enable successful study delivery. The GSD may provide input to early study planning activities based on operational expertise. The GSD is accountable to the CPT for the delivery of a study, or studies, according to agreed upon timelines, budget and quality standards by ensuring an effective partnership and teamwork within the study team. The GSD will also interface with other internal stakeholders cross-functionally, and/or external partners, to identify, manage and resolve issues affecting study delivery. The GSD leads the study team(s) and/or study oversight team(s) in accordance with the Study Team Operating Model for Internal Delivery (SOLID), Project Management Framework and/or clinical outsourcing model, current clinical trial regulations (e.g. ICH GCP), Standard Operating Procedures (SOPs), policies and best practices and in line with our values and behaviours. The GSD is also responsible for providing expert guidance, direction, mentoring, and support to Global Study Managers on their studies, for study specific activities. What You'll Do: - Lead and coordinate a cross-functional study team of experts in accordance with SOLID and its roles, accountabilities and responsibilities framework (RACI) to ensure the clinical study progress as planned driving achievement of milestones according to timelines, budget and quality standards. - Contribute to vendor/ESP selection activities at the study level, including bid defense, and lead operational oversight at the study level in order to ensure appropriate control over the vendor identification and selection. - Collaborate with other functions to establish strategies and identify synergies aimed at increasing efficiency of global study teams (core and extended). - Lead and facilitate communication across functions and provide guidance and support to the core and extended study team members as needed and in accordance with study-specific communication plan. - For outsourced studies, be the primary sponsor point of contact for the CRO Study Manager to ensure study delivery according to agreed upon timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant SOPs and guidelines (e.g. description of services and transfer of obligations). - Provide operational expertise into and hold accountability for the development of essential study level documents (i.e. Clinical Study Protocol (CSP) through to Clinical Study Report (CSR)) in accordance with relevant SOPs. - Ensure all external service providers (i.e. central laboratories, IXRS, ePRO, etc.) engaged at the study level are performing to contracted goals and timelines/budget and that adequate oversight is documented through planning & control activities. - Develop and maintain relevant study plans (e.g. global study management plan and its relevant components such as study project plan SPP) including required input into study level quality and risk management planning (e.g. risk-based quality management, proactive risk and contingency plans, etc.), ensuring that the risk response strategies and issue escalation pathways are clear to the entire study team. - Oversee study level performance against agreed upon plans, milestones and key performance indicators (KPIs, quality and operational) by using company tracking systems and project timelines (e.g. SPP, data flow metrics dashboard, CTMS or eTMF dashboard) and communicate any risks to timelines and/or quality to CPT, along with proposed mitigations. - Providing expert guidance, direction, mentoring, and support to Global Study Managers on their studies, for study specific activities. - Identify and report quality issues that have occurred within the study in accordance with relevant SOP and collaborate with all functions as necessary to overcome barriers and achieve milestones; proactively communicate findings and corrective action plans (CAPAs) to relevant stakeholders (e.g. CPT, quality assurance staff, functional line management, etc.). - Oversee Trial Master File (TMF) completion in accordance with relevant AZ SOPs, including ensuring the TMF plan and Expected Document List (EDL) are in place and that QC activities are performed on an ongoing basis to ensure TMF completeness at all times. - Ensure timely compliance with company-wide governance controls (e.g. Delegation of Authority, Sunshine Act, financial attestations, Clinical Trial Transparency). - Responsible for study budget re-forecasting following initial budget estimate provided by the CPTand accountable for study budget management through the study lifecycle and for providing budget progress reports to the CPT including any financial risks and mitigation plans (as part of the ongoing study change control process). - Ensurestudiesareinspection-readyatalltimes,accordingtoICH-GCPandSOPandrelevant policies/guidelines. GSD is the primary CTCO Clinical Operations point-of- contact in the event of an audit or inspection. - Provideregularfeedbackonindividualperformancetothestudyteammembersandtheirline managers to support their professional development. - Provideguidance,training,expertinput,mentoringandsupportto lessexperiencedGSL colleagues on an ongoing basis. - Leads non-drug project work such as CTCO representative in process improvements and/or leading improvement projects as discussed and agreed upon with their manager Education & Experience Requirements: ·Universitydegree(orequivalent),preferablyin medical or biological sciences or discipline associated with clinical research ·Provenprojectmanagementexperienceand training ·At least 10 yearsofclinicaltrialexperience ·Atleast 5 yearsofexperienceinglobalstudy leadership and team leadership ·Demonstratedclinicaltrialexpertisein Oncology Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions. Knowledge, Skills, Abilities: • Comprehensive therapeutic area knowledge, clinical development guidelines and directives and regulatory guidelines • Expert knowledge of the key principles of cross functional project management (Time, Quality, Cost) • Excellent oral and written communication and presentation skills • Demonstrated leadership and interpersonal skills including the ability to lead, motivate and coordinate cross-functional project teams • Technical and systems competency, such as computer skills, to include effective use of systems and applications such as Microsoft Outlook, Word, Excel and PowerPoint, as well as organization systems (CTMS, Preclarus, Clarity) • Proven flexibility and ability to effectively prioritize workload and resources for project team members in a frequently changing environment • Skilled in process improvement and strategic development, especially as it applies to clinical trials, clinical development and project management • Ability to coach, mentor and lead global and/or cross-functional teams with a cultural awareness • Strong financial acumen with an in-depth of knowledge and practical application of budgeting, forecasting and resource management. Project Lead • Excellent customer service, consultation and relationship building skills • Advanced negotiation and marketing skills with ability to influence others and drive results • Excellent judgment, decision making and problem-solving skills and proven ability to apply critical and analytical strategic thinking skills to manage complex/ambiguous situations • Proactive, solutions oriented and skilled at risk identification and management. Project Oversight • Excellent customer service and relationship building skills with the ability to proactively address and prioritize expectations • Strong executive presence and business acumen • Advanced negotiation and marketing skills with ability to influence others and drive results • Proactive, solutions oriented and skilled at risk management • Excellent judgment, decision making and problem-solving skills and proven ability to apply critical and analytical strategic thinking skills to manage complex/ambiguous situations • Ability to drive corporate strategies to capture, engage and retain repeat customers People Manager • Ability to identify and address training gaps for soft skill and technical development, including managing performance stewardship, metrics and retention • Excellent judgment, decision making and problem-solving skills and proven ability to apply critical and analytical strategic thinking skills to drive development and retention of top performers • Proven ability to act as a change champion • Ability to collaborate and foster accountability in a learning environment • Ability to drive process improvement and strategic initiatives • Strong negotiation skills with ability to influence others and drive results.
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Director, Clinical Operations
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Essential Duties & Responsibilities Postpartum Support International (PSI) works to promote awareness, prevention, and treatment of mental health issues related to childbearing. PSI supports families, provides expert training to providers, and creates a bridge between families and informed resources. PSI disseminates information and resources through its volunteers, website, training, chapters, and annual conference. PSI board and staff are dedicated and passionate individuals committed to alleviating distress and improving outcomes for pregnant and postpartum families. PSI headquarters is in Portland, Oregon, but the position is entirely remote. PSI additionally operates the National Maternal Mental Health Hotline, a 24/7 hotline federally funded by the Health Resources and Services Administration (HRSA). The Manager, Clinical Practice & Operations is a senior operational and clinical leadership role responsible for building and sustaining the infrastructure that enables the National Maternal Mental Health Hotline to deliver consistent, high-quality, evidence-based care at scale. This role owns the clinical practice ecosystem, spanning training architecture, protocol development and refinement, clinical standards, and the direct management and development of the Clinical Supervisor team. This is not a primarily direct-service role. It is a systems-thinking, people-developing, and process-building leadership position that requires the ability to see across the full clinical operation, identify gaps before they become problems, and drive continuous improvement with rigor and urgency. The Manager, Clinical Practice & Operations serves as the Hotline’s foremost subject matter expert on clinical service delivery, practice standards, and operational readiness and partners closely with the Associate Program Manager and Data Manager/CQI Specialist on quality improvement activities without duplicating those functions. 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Training Architecture & Protocol Development (40%) - Own the clinical training infrastructure for all Hotline staff, including the design, sequencing, delivery, and ongoing evaluation of standardized orientation, onboarding, and continuing education curricula. - Lead the development and maintenance of the Training and Orientation Plan, with particular attention to clinical services content, measurable competency benchmarks, and timelines that reflect operational realities. - Establish and maintain a systematic process for identifying clinical training gaps through case audits, live monitoring findings, and Clinical Supervisor input, translating findings into actionable curriculum updates and protocol refinements. - Drive the refinement of clinical protocols in response to counselor performance trends, help-seeker outcome patterns, and contractual requirements, documenting all changes and ensuring effective communication and retraining across the team. - Collaborate with the Data Manager/CQI Specialist to ensure data quality processes (including the Universal Data Quality Process, CARE Process, Quality Contact Monitoring, and Case Auditing) are functionally supporting clinical operations; translate findings into clinical improvements and training responses. - Analyze contact data and trend patterns monthly to surface clinical service gaps, counselor support needs, and opportunities for protocol or resource enhancement, reporting findings and recommended actions to Hotline leadership. - Support the Hotline Services team in the hiring process for Hotline Counselor staff by contributing clinical expertise to interviews, onboarding design, and skill-mix assessment. - Maintain accurate records of counselor credentials, licensure, and liability insurance in collaboration with the Associate Program Manager and Workforce Enablement Specialist, ensuring ongoing compliance. - Maintain accurate and confidential records, ensuring compliance with relevant laws and regulations. Hotline Communications, Collaboration & Teamwork (15%): - Participate actively in all required Hotline leadership/administrative meetings, quality improvement sessions, strategy workgroups, and trend data reviews. - Provide regular, structured updates to Hotline Executive Staff and Project Leadership on clinical practice performance, emerging needs, and recommended actions. - Manage the Clinical Supervisor team schedule to ensure adequate, consistent coverage across all operational hours. - Facilitate routine 1:1 meetings with Clinical Supervisors to disseminate information, monitor performance, and support professional growth. - Lead independent Clinical Practice team meetings to facilitate team cohesion, information sharing, and operational momentum. - Develop and sustain strong collaborative relationships with internal staff, committees, and external organizations to advance the Hotline’s clinical quality and engagement goals. - Respond promptly to requests from the Project Director, Associate Program Manager, Contracts and Special Projects Specialist, and HRSA Project Leads. Operational Need & Surge Protocol Response (5%): In the event of an anticipated surge in Hotline volume, and in alignment with the Surge Protocol, provide live phone, text, and web chat support, adhering to all Hotline Counselor protocols and practices. This is activated only upon request during actively scheduled working hours; no flex time or overtime is required. Education and/or Work Experience Requirements - Master’s degree or higher in clinical social work, counseling, psychology, or a related field required. - Active, unrestricted professional licensure required: Licensed Clinical Social Worker (LCSW), Licensed Professional Counselor (LPC), or Licensed Mental Health Counselor (LMHC). - Minimum of four (4) years of management experience, with demonstrated responsibility for team performance, staff development, and operational outcomes, preferably in behavioral, mental, or public health settings. - Minimum of five (5) years of post-master’s clinical experience in mental health services. - Documented clinical supervision training and qualifying supervised hours required. - Demonstrated experience in perinatal mental health service delivery and working with diverse populations. Knowledge of maternal health issues, perinatal mood disorders, and related topics. - Proven ability to build and manage clinical practice systems, including training programs, protocol development cycles, and practice standards infrastructure, not solely direct clinical service delivery. - Strong analytical skills with the ability to interpret contact data and translate findings into operational decisions and clinical improvements. - Demonstrated capacity to develop and directly manage clinical supervisors, including coaching staff toward systems-level thinking and operational accountability. - Knowledge of trauma-informed, culturally responsive, and linguistically accessible counseling frameworks. - Familiarity with crisis intervention best practices and the ability to lead effectively under pressure. - Knowledge of relevant laws, regulations, and ethical standards governing mental health practice and client confidentiality. Additional Eligibility Qualifications - Must complete and clear a Non–Sensitive Tier II - Moderate Check and Clearance background check (administered by HHS). - Must be able to commit to the Postpartum Support International vision and be passionate about its mission. - Must possess optimal (high) internet speeds and be able to maintain optimal speeds for the utility of operating systems and platforms. - Excellent verbal and written communication skills, including the ability to translate complex clinical information for diverse internal and external audiences. - Ability to work flexible and non-traditional hours as operational needs require. - Ability to work independently, exercise sound judgment, and drive work to completion with minimal direction. - Ability to manage competing priorities and respond to unpredictable, high-acuity situations with a calm, solution-oriented approach. - Active state licensure in good standing is maintained throughout employment. - Dedicated, quiet, and secure workspace ensuring privacy and confidentiality. What We Offer - A deep commitment to fostering a culture where everyone feels respected, valued, and supported. - A fully remote, asynchronous work environment that empowers you to work where and when you’re most effective while maintaining a healthy work-life balance. - Ongoing professional development opportunities to help you grow your skills and expand your network. - A comprehensive benefits package focused on your well-being, including medical, dental, and vision coverage. - Generous paid time off, including vacation (two weeks), holidays, sick leave, and personal days (three). - Inclusive parental leave (twelve weeks) supporting all paths to parenthood, along with resources to help balance family responsibilities - Comprehensive retirement plan option with an organization-provided match to support your long-term financial goals. Physical Requirements - Ability to safely and successfully perform the essential job functions consistent with the ADA, and other federal, state, and local standards, including meeting qualitative and/or quantitative productivity standards; - Required to sit, stand, walk, speak, and hear while performing the duties of this job regularly. The position requires extensive computer use, so the employee must have sufficient hand dexterity to use a computer keyboard and be capable of reading a computer screen. In-Person Availability - While this role is predominantly a remote position, travel and in-person meeting attendance are required up to two times per year for internal PSI meetings, and as needed for contractually essential stakeholder engagements (estimated no more than twice per year). Equal employment opportunity and having a diverse staff are fundamental principles at Postpartum Support International, where employment and promotional opportunities are based upon individual capabilities and qualifications without regard to race, color, religion, gender, pregnancy, sexual orientation/affectional preference, age, national origin, marital status, citizenship, disability, veteran status or any other protected characteristic as established under law. Postpartum Support International does not discriminate against formerly incarcerated individuals.


