Program Manager, Tmf Operations

hace 2 días


Edo de México Syneos Health Clinical A tiempo completo

**Description**

**Program Manager, Trial Master File (TMF) Operations**

Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:
**WORK HERE MATTERS EVERYWHERE**

**Why Syneos Health**
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.

**Job responsibilities**
- Participates in bid defense meetings and general capabilities presentations to grow TMF Operations Portfolio of work. Provides eTMF system demonstrations to perspective and existing clients.
- Evaluates and manages budgets across the portfolio to ensure appropriate TMF Operations revenue recognition is achieved.
- Implements processes and manages access/training for the company and/or client eTMF technologies.
- Develops portfolio level templates for TMF Plans and/or TMF related training.
- Presents and/or ensures TMF related training is effectively provided to the company, client and vendor project team members.
- Assesses and collaborates on resource needs for assigned portfolios.
- Collaborates with client to establish appropriate portfolio progress and business metrics to ensure TMF objectives are met.
- Oversees the portfolio level deliverables and KPIs.
- Liaises with the TMF Leads Management to ensure consistency on the TMF projects oversight, including projects performance and KPIs management across portfolios.
- Supports and mentors TMF Leads on TMF project oversight for assigned portfolio.
- Evaluates and documents potential TMF risks to their assigned portfolios and develops/implements mitigation strategies. Manages escalations by following the approved communication pathway informing TMF Operations Leadership and client, as applicable.
- Maintains effective communication with the client, Strategic Alliance Management team, TMF Operations team and project team through oral and written correspondence, portfolio level TMF Health KPIs reporting and Program Review Meetings ensuring adequate documentation of each communication.
- Prepares information for internal and client meetings. May attend Trusted Process event meetings, client operations meetings, project team meetings, and training sessions.
- Prepares and participates in audits/inspections to ensure ongoing readiness of the TMF.
- Actively participates in professional organizations to keep abreast of best practices.
- Performs oversight, hiring, training and management of TMF Operations team members such as interviewing, selection and task management, as applicable.
- Minimal travel may be required (up to 25%). Performs other work-related duties as assigned.

**Qualifications**

**What we’re looking for**
- Undergraduate degree and experience managing a program/portfolio with direct experience managing client relationships.
- Moderate experience in a clinical and/or medical environment that includes working with regulatory records.
- Experience leading team members through direct or indirect line management preferred.
- Strong knowledge of appropriate regulations and guidelines with respect to regulatory documents and familiarity with medical terminology.
- Demonstrated leadership skills.
- Strong verbal, written, and organizational skills with a team-oriented approach.
- Ability to handle multiple tasks to meet deadlines in a dynamic environment.

**Get to know Syneos Health**
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites


  • Tmf Lead Ii

    hace 3 semanas


    Edo. de México Syneos Health Clinical A tiempo completo

    **Description** **Trial Master File (TMF) Lead II** Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help...


  • Ciudad de México Worldwide Clinical Trials A tiempo completo

    **Requisition Number** **7277** **Employment Type***: **Regular** **Who we are** Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our...


  • Ciudad de México TMF Group A tiempo completo

    **About TMF Group** TMF Group is a leading provider of critical administrative services, helping clients invest and operate safely around the world. We provide legal, financial and employee administration through TMF Group’s teams in 120 offices TMF Mexico is looking for an Accounting Coordinator to work on a hybrid modality from Ciudad de...


  • Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completo

    Requisition Number7032Employment Type:RegularWho we areWorldwide, a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company's scientific heritage, our dedicated therapeutic focus on...

  • Tmf Lead

    hace 2 semanas


    Ciudad de México, Ciudad de México ICON A tiempo completo

    At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration,...

  • Becario de Contabilidad

    hace 4 semanas


    Ciudad de México TMF Group A tiempo completo

    **Job no**: 564521 **Work type**: Intern, Part time **Location**: Mexico City, Mexico **Categories**: Client Accounting, Entry Level **Office Location**: Mexico City Muchas Personas. Un solo TMF. TMF Group es un proveedor líder de servicios administrativos esenciales que ayuda a sus clientes a invertir y operar de manera segura en todo el mundo....

  • Team Lead, Tmf Operations

    hace 3 semanas


    Ciudad de México Worldwide Clinical Trials A tiempo completo

    **Requisition Number** **7036** **Employment Type***: **Regular** **Who we are** Worldwide Clinical Trials (Worldwide), a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our...


  • Ciudad de México Worldwide Clinical Trials A tiempo completo

    **Requisition Number** **6707** **Employment Type***: **Regular** **Who we are** We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with...


  • Ciudad de México Worldwide Clinical Trials A tiempo completo

    **Requisition Number** **7032** **Employment Type***: **Regular** **Who we are** Worldwide, a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company’s scientific heritage, our...

  • Operations Manager

    hace 2 días


    Edo. de México Servicios Comerciales Amazon Mexico S. de R.L. de C.V. A tiempo completo

    3+ years of employee and performance management experience - Bachelor's degree or equivalent, or 2+ years of Amazon (blue badge/FTE) experience - Work a flexible schedule/shift/work area, including weekends, nights, and/or holidays Amazon is seeking Operations Managers for Fulfillment Centers (FCs). Amazon is one of the most recognizable brand names in the...

  • Analista Contable

    hace 2 meses


    Ciudad de México TMF Group A tiempo completo

    TMF Group es un proveedor líder de servicios administrativos esenciales que ayuda a sus clientes a invertir y operar de manera segura en todo el mundo. Proporcionamos administración legal, financiera y de personal a través de los equipos de TMF Group en 120 oficinas. **Descrube el rol**: - Preparación de Papeles de Trabajo - Contacto directo con...


  • Ciudad de México, Ciudad de México TMF Group A tiempo completo

    Acerca de TMF Group: TMF Group es un proveedor líder de servicios administrativos esenciales que ayuda a sus clientes a invertir y operar de manera segura en todo el mundo. Proporcionamos administración legal, financiera y de personal a través de los equipos de TMF Group en 120 oficinas. Descrube el rol: Apoyar la ejecución exitosa de todas las...


  • Ciudad de México Worldwide Clinical Trials A tiempo completo

    **Requisition Number**7564** **Employment Type**:Regular** **Who we are** Worldwide, a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company’s scientific heritage, our...


  • Ciudad de México, Ciudad de México Offices, Boards And Divisions A tiempo completo

    Assists the Program Manager with managing a police development project based in a foreign country, acting as an authoritative representative directing the delivery of training and technical assistance activities. Assists the Program Manager with reviewing, creating, and improving law enforcement policies and programs as they pertain to career development and...

  • Capital Markets Manager

    hace 4 semanas


    Ciudad de México TMF Group A tiempo completo

    **Job Purpose**: **KEY RESPONSIBILITIES AND QUALIFICATIONS**: The role includes but is not limited to the responsibilities listed below. - Cooperate with the Global Head, Latam Coordinator and US based colleagues in pitching TMF’s North Latin America capital markets capabilities to US and Mexican law firms, banks and other intermediaries; - Cooperate with...

  • Becario de Contabilidad

    hace 2 semanas


    Ciudad de México, Ciudad de México TMF Group A tiempo completo

    Job no: 564521Work type: Intern, Part timeLocation: Mexico City, MexicoCategories: Client Accounting, Entry LevelOffice Location: Mexico CityMuchas Personas. Un solo TMF.TMF Group es un proveedor líder de servicios administrativos esenciales que ayuda a sus clientes a invertir y operar de manera segura en todo el mundo. Proporcionamos administración legal,...


  • Ciudad de México, Ciudad de México Worldwide Clinical Trials A tiempo completo

    Requisition Number7564**Employment Type:Regular**Who we areWorldwide, a leading global contract research organization (CRO), works in partnership with biotechnology and pharmaceutical companies to create customized solutions that advance new medications - from discovery to reality. Anchored in our company's scientific heritage, our dedicated therapeutic...


  • Ciudad de México, Ciudad de México TMF Group A tiempo completo

    En TMF Group nunca pedimos pagos como parte de nuestro proceso de selección, y siempre contactamos a los candidatos/as por medio de cuentas o plataformas corporativas. Si en algún momento recibe una invitación para hacer un pago, es posible que se trate de un fraude. Por favor revise si el rol en el cuál se encuentra interesado/a se encuentra publicado...

  • Capital Markets Manager

    hace 2 semanas


    Ciudad de México, Ciudad de México TMF Group A tiempo completo

    Job Purpose:KEY RESPONSIBILITIES AND QUALIFICATIONS:The role includes but is not limited to the responsibilities listed below. Cooperate with the Global Head, Latam Coordinator and US based colleagues in pitching TMF's North Latin America capital markets capabilities to US and Mexican law firms, banks and other intermediaries; Cooperate with Capital Market...


  • Ciudad de México, Ciudad de México TMF Group A tiempo completo

    Acerca de TMF Group: TMF Group es un proveedor líder de servicios administrativos esenciales que ayuda a sus clientes a invertir y operar de manera segura en todo el mundo. Proporcionamos administración legal, financiera y de personal a través de los equipos de TMF Group en 120 oficinas. Descrube el rol: • Gestión del equipo para asegurar que...