Senior Clinical Project Manager, Internal Medicine

hace 7 meses

Buenos Aires, Argentina Novasyte A tiempo completo

POSITION TITLE: Senior Project Manager

REPORTS TO: Director, Project Management or Designee

BASIC FUNCTIONS:
Responsible for the successful planning, implementation and execution of contracted activities. Assures the accurate transfer of contracts from proposal through project completion. Functionally responsible for all team members throughout the duration of each clinical trial. Assures clear client communication, process documentation, and compliance with Good Clinical Practices (GCP) and procedures set forth by IQVIA Biotech and sponsors. Supports the department director in development of functional training, mentoring, and definition of standards and execution of department goals including process improvement.

ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES:
Responsible for all activities related to implementation of clinical studies including:

- Manages projects of full scope regional and global projects. Responsible for project team leadership
- Responsible for building and maintaining positive client relationships
- Ability to negotiate with clients to assure IQVIA Biotech’s operational processes are maintained, projects are done within scope
- Reviewing and identifying project study trends and _proactively_ responding to client and respective team members
- Developing appropriate early warning systems of potential obstacles to the successful completion of the projects; analyzes information and develops innovative solutions to challenges
- Identifying, define, document training requirements in LMS systems and assure project level compliance with study specific training requirements
- Responsible for change management on all assigned projects
- Responsible for assuring projects assigned are run according to SOPs and WP as refined in the contract
- Responsible for assuring project timelines are met as per contract
- Responsible for identifying processes which need updating and documenting that to the direct line manager or divisional lead
- Responsible for maintaining client relationships for all assigned work, keeping all project reporting current, and assuring executive management is aware
- In conjunction with management, assists with developing, documenting, and updating internal processes and processes required for consistency across programs such as SOPs, working practices, and related quality assurance forms.
- Provide other project support to Managers, as assigned
- Oversee delegation of support staff activities, as necessary
- Assists in the development and delivery of capability and proposal defense presentations to prospective clients
- Supports Contracts and Proposals with final project contract execution and CIS documentation by the project team. Represents senior management in negotiation of contracts as appropriate.
- Participates in the performance appraisal program by providing timely and accurate feedback regarding the performance of respective team members at least annually
- Maintains current knowledge of FDA regulations, and GCP and ICH Guidelines for clinical research.
- Responsible to maintain personal currency documentation for IQVIA Biotech SOPs, CAPA completion and timesheet maintenance including assurance or back-up PM staff at every instance of out of office

KNOWLEDGE, SKILLS AND ABILITIES:

- Thorough knowledge of clinical research process from Phase I through regulatory submission
- Strong communication skills (verbal and written) to express complex ideas
- Excellent and demonstrated organizational and interpersonal skills
- Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities
- Ability to manage multiple priorities within a variety of complex clinical trials
- Ability to reason independently for the purpose of assessing and recommending specific solutions in clinical settings
- Ability to set baseline targets, track trends and implement mitigation plans
- Understanding of basic data processing functions, including electronic data capture
- Demonstrated problem-solving and financial negotiation skills
- Working knowledge of current ICH GCP guidelines

CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA:

- Very limited physical effort required to perform normal job duties.
- Up to 20% travel may be required including international travel
- Must be able to secure a credit card cosigned by IQVIA Biotech

MINIMUM RECRUITMENT STANDARDS:

- Previous Management Requirements:

- Nursing or University degree (US Bachelor Level or equivalent) in a health-related field with at least five (5) years direct clinical trial experience in a CRO or research-related organization with at least two (2) years management experience OR
- Equivalent level of education and experience.
- Previous experience in managing people within a scientific/clinical environment is required.
- Demonstrated Clinical Monitoring and/or Data Management experience required.
- Excellent verbal and written communication and presentation skills re

  • Project Mgr/senior Project Mgr, Global Clinical

    hace 7 meses

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving...

  • Project Mgr/senior Project Mgr, Global Clinical

    hace 7 meses

    Buenos Aires, Argentina Thermo Fisher Scientific A tiempo completo

    We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving...

  • Medical Monitor

    hace 3 meses

    Buenos Aires, Argentina PSI CRO A tiempo completo

    **Company Description** PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. PSI **Medical Monitors **provide medical input to global...

  • Clinical Trial Project Manager

    hace 2 días

    Buenos Aires, Argentina Medpace, Inc. A tiempo completo

    Job Summary: Medpace is the leading CRO for Biotech companies and is continuing to add and established Clinical Trial Managers / Project Managers to join our Clinical Trial Management Group in **Buenos Aires, Argentina**. Our therapeutic areas of focus include Oncology, Cardiovascular/Metabolic, Infectious Disease, CNS and more. We offer a very competitive...

  • Senior Translations Project Manager

    hace 7 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    SENIOR PROJECT MANAGER Working with the wider Project Management team, the Senior Project Manager is responsible for coordinating and managing the full lifecycle of translation and localization projects to completion whilst ensuring IQVIA’s standards are met. - Manage multiple translation and localization projects at any one time from receipt to...

  • Senior Clinical Associate

    hace 6 meses

    Buenos Aires, Argentina Icon plc A tiempo completo

    Senior Clinical Associate - Buenos Aires, Argentina ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of...

  • Senior Clinical Associate

    hace 7 meses

    Buenos Aires, Argentina ICON A tiempo completo

    **Senior Clinical Associate - Buenos Aires, Argentina** ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre...

  • Senior Clinical Associate

    hace 7 meses

    Buenos Aires, Argentina ICON plc A tiempo completo

    **Senior Clinical Associate - Buenos Aires, Argentina** ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre...

  • Associate Clinical Project Manager, Immuno-oncology

    hace 6 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    BASIC FUNCTIONS: Provides project-related support to the Program, Senior, and Project Manager(s) and other project team members from proposal development through final deliverable. ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: - Manages projects of limited scope (functional or regional). Responsible for project team leadership. - Responsible for...

  • Senior Clinical Trial Manager, Oncology, Argentina

    hace 7 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    Required: 3+ years of Clinical Trial Management experience (CRO experience preferred). Experience managing clinical trials in LATAM and North America required Oncology experience related to managing studies Fluent in English, both writing and verbally Preferred: Experience managing global studies Experience managing studies in other therapeutic areas...

  • Associate Clinical Project Manager, Immuno-oncology

    hace 6 meses

    Buenos Aires, Argentina IQVIA A tiempo completo

    **BASIC FUNCTIONS**: Provides project-related support to the Program, Senior, and Project Manager(s) and other project team members from proposal development through final deliverable. **ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES**: - Manages projects of limited scope (functional or regional). Responsible for project team leadership. -...

  • Sr. Clinical Project Manager, Immuno-oncology and

    hace 7 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    PLEASE SUBMIT RESUMES IN ENGLISH.BASIC FUNCTIONS: Responsible for the successful planning, implementation and execution of contracted activities. Assures the accurate transfer of contracts from proposal through project completion. Functionally responsible for all team members throughout the duration of each clinical trial. Assures clear client communication,...

  • Clinical Trial Manager

    hace 2 meses

    Buenos Aires, Argentina ICON Plc A tiempo completo

    Senior Clinical Trial Manager - Argentina, Buenos Aires ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Senior...

  • Sr. or Clinical Trial Manager Ii, Oncology;

    hace 7 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    IQVIA Biotech is committed and dedicated to the small biotech & biopharma companies we support. Opportunities available for an experienced Clinical Trial Manager II or Senior Clinical Trial Manager. Previous clinical trial management and CRO experience preferred. Therapeutic requirements/preference: any of the following Oncology/Hematology/CAR T/Cell &...

  • Clinical Trial Manager-oncology

    hace 2 meses

    Buenos Aires, Argentina ICON Plc A tiempo completo

    Clinical Trial Manager, Oncology - LATAM / Remote ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking a Clinical Trial...

  • Clinical Scientist, Cronos

    hace 2 meses

    Buenos Aires, Argentina IQVIA A tiempo completo

    Job Overview Associate Clinical Leads are an integral part of clinical trial delivery, working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Associate Clinical Lead is a member of the core project team responsible for clinical delivery of clinical studies to meet contractual requirements in accordance...

  • Senior Translations Project Manager

    hace 7 meses

    Buenos Aires, Argentina IQVIA A tiempo completo

    SENIOR PROJECT MANAGER Working with the wider Project Management team, the Senior Project Manager is responsible for coordinating and managing the full lifecycle of translation and localization projects to completion whilst ensuring IQVIA’s standards are met. - Manage multiple translation and localization projects at any one time from receipt to...

  • Manager, Clinical Operations

    hace 6 meses

    Buenos Aires, Argentina Icon plc A tiempo completo

    Requirements: - Located in Argentina- Bachelor’s degree- Advanced English Level- Minimum 6 years Clinical Research experience that includes a minimum 4 years relevant experience as a Senior CRA or Principal CRA (in a Lead CRA role), or at least 2 years as a CRA Manager or equivalent job role.- Knowledge of ICH-GCP guidelines and ability to review and...

  • Clinical Operations Manager

    hace 7 meses

    Buenos Aires, Argentina ICON plc A tiempo completo

    **Requirements**: - Located in Argentina - Bachelor’s degree - Advanced English Level - Minimum 6 years Clinical Research experience that includes a minimum 4 years relevant experience as a Senior CRA or Principal CRA (in a Lead CRA role), or at least 2 years as a CRA Manager or equivalent job role. - Knowledge of ICH-GCP guidelines and ability to review...

  • Contract Project Manager

    hace 7 meses

    Buenos Aires, Argentina Acolad A tiempo completo

    **Acolad is an international leader in language and content solutions, services, and technologies. Represented by the brands Acolad, Livewords, TextMaster and Ubiqus, the group is present in 25 countries and has a network of over 2,500 internal experts worldwide and +20,000 external linguists.** **At Acolad, every position is key to our global growth: we...