Manager, Clinical Practice and Operations

Location

United States

Posted

93 days ago

Salary

0

Seniority

Lead

No structured requirement data.

Job Description

Manager, Clinical Practice and Operations

Postpartum Support International

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. How You Will Contribute As the Manager, Clinical Practice and Operations, you will perform the following and/or similar activities: Clinical Practice Leadership & Oversight (40%) - Serve as the clinical practice subject matter expert for the Hotline, owning the design, implementation, maintenance, and continuous refinement of clinical protocols, service delivery standards, and evidence-based practice frameworks specific to perinatal mental health. - Provide direct management and full performance oversight of the Clinical Supervisor team, including routine 1:1s, performance evaluations, professional development planning, and accountability to role expectations. - Partner with and develop Clinical Supervisors to ensure they are functioning as effective team leads, coaching them to see the big picture of clinical operations, not only their individual caseloads or shift responsibilities. - Lead the ongoing review cycle for all clinical protocols and procedures, ensuring they remain current, evidence-informed, and aligned with contractual obligations and emerging field standards. - Establish and maintain a structured cadence for protocol review, escalation pathways, and clinical decision-making frameworks so that Hotline Counselors have clear, reliable guidance in high-acuity situations. - Monitor the external environment, including current events, public health developments, and emerging perinatal mental health research, to proactively anticipate shifts in caller needs and adjust clinical guidance accordingly. - Foster partnerships with Hotline leadership to determine and implement clinical best practices, informing strategic development and ensuring clinical services remain aligned with project goals. - Conduct or oversee clinical case audits, live monitoring, quality contact monitoring, and 1:1 clinical supervision with Hotline Counselors as needed to maintain practice quality and support counselor development. 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.

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Team Interactions - Represent SSU on cross-functional teams, providing updates, escalating challenges, and proposing mitigation strategies for site start-up issues. - Act as the escalation point for CRO and internal team to ensure timely SSU issue resolution Process Improvement - Recommends and participates in cross functional and department process improvements. - May require up to 25% travel From you we expect - Bachelor degree - Minimum 4 - 6 years regulatory submission experience at global level, regulatory document management in Pharmaceutical /CRO industry , understanding of clinical study start up requirements and working knowledge of relevant documentation. - Project Management and Clinical Trial Management experience is a must. - Demonstrated interpersonal & leadership skills - Ability to understand and implement the operational strategic direction and guidance for respective clinical studies - A data driven approach to planning, executing, and problem solving - Effective communication skills via verbal, written and presentation abilities - Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization - Ability to influence and negotiate across key stakeholders - Ability to build productive study teams collaborations - Experience in the clinical drug development process, with expertise in study start-up - Demonstrated vendor management experience - Technical proficiency in trial management systems (CTMS, TMF) and MS applications including (but not limited to) Project, PowerPoint, Word, Excel - Knowledge of ICH/GCP and regulatory guidelines/directives - Effective project management skills, cross-functional team interaction and organizational skills For an immediate interview, please contact marta.kuniewicz@parexel.com

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When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. If you want to be part of a leading CRO and transform scientific discoveries into new treatments, then Parexel FSP challenges you to live up to your potential by joining us at Global Site Start-Up II, home-based and sponsor dedicated, in Poland/Spain/Romania/Serbia/Ukraine. In this role you will be is accountable for the global execution of site activation for assigned clinical trials, performing responsibilities with moderate oversight. 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Expect exciting professional challenges in inspiring studies, but with time for your outside life. The most significant aspect of this position is Site Start-up Strategy - Develop the site start up strategy for each study, outlining all dependencies impacting site activation and actively mitigating and escalating risks. Oversee the tracking and analysis of study metrics, including risks and mitigation strategies and to evaluate CRO performance and implement corrective actions. - Advocate for optimized site selection strategies, leveraging data-driven insights to guide cross-functional teams toward effective decision-making. - Lead the development, assessment, and alignment of site activation projections, ensuring cross-functional and CRO collaboration to meet strategic objectives. - Ensure comprehensive and compliant documentation of site start-up materials in the Trial Master File (TMF) to maintain inspection readiness. 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Team Interactions - Represent SSU on cross-functional teams, providing updates, escalating challenges, and proposing mitigation strategies for site start-up issues. - Act as the escalation point for CRO and internal team to ensure timely SSU issue resolution Process Improvement - Recommends and participates in cross functional and department process improvements. - May require up to 25% travel From you we expect - Bachelor degree - Minimum 4 - 6 years regulatory submission experience at global level, regulatory document management in Pharmaceutical /CRO industry , understanding of clinical study start up requirements and working knowledge of relevant documentation. - Project Management and Clinical Trial Management experience is a must. - Demonstrated interpersonal & leadership skills - Ability to understand and implement the operational strategic direction and guidance for respective clinical studies - A data driven approach to planning, executing, and problem solving - Effective communication skills via verbal, written and presentation abilities - Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization - Ability to influence and negotiate across key stakeholders - Ability to build productive study teams collaborations - Experience in the clinical drug development process, with expertise in study start-up - Demonstrated vendor management experience - Technical proficiency in trial management systems (CTMS, TMF) and MS applications including (but not limited to) Project, PowerPoint, Word, Excel - Knowledge of ICH/GCP and regulatory guidelines/directives - Effective project management skills, cross-functional team interaction and organizational skills For an immediate interview, please contact marta.kuniewicz@parexel.com

Lithuania + 5 moreAll locations: Lithuania | Oman | Poland | Romania | Serbia | Ukraine
Job Closed