Site Activation Specialist I

2 tygodni temu

Warszawa, Mazovia, Polska Syneos Health, Inc. Pełny etat

Updated: Yesterday
Location: Poland-Europe - POL-Warsaw-Hybrid
Job ID:25002696

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

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

General:

  • Responsible for providing quality on deliverables at the country level and follows project requirements and applicable country rules, with oversight from the SSU Country Manager.
  • Works within the forecasted submission/approval timelines and ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time; if forecasted timelines are not reached provides clear rationale for delays, assists with contingency plan to mitigate impact, and escalates the issue as soon as identified.
  • Monitors basic financial aspects of the project and the number of hours/tasks available per contract; escalates discrepancies in a timely fashion.
  • Reviews and complies with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner, keeps training records updated accordingly and ensures timesheet compliance.
  • Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.

Responsible for one or more of the following functions at the country level:

  • Local Submissions Specialist - Follows the project direction provided by the designated country start-up advisor (CSA) and SAL. May serve as a point of contact for the SAL/PM (or designee) during start-up on allocated projects. Compiles and/or reviews essential document packages for site activation and may also be involved in essential document collection from site.
  • Prepares and submits Central EC Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required and under supervision. Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules, with oversight from the SSU Country Manager.
  • May act as liaison and facilitator between investigational sites and functional leads for related tasks and/or issues. Oversee site activation end to end process at country/ site level.
  • Local Site ID and Feasibility Support – Provides support with site selection lead and PM/SAL to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
  • Local Investigator Contract and Budget Negotiator – Supports the SAL to agree on country template contract and budget. Assists in producing site-specific contracts from country template. Under supervision assist in negotiations of budget and contract with site and via Site Contracts Service Centre and SAL lead with Sponsor until resolution of issues and contract execution. Assists with quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.

Qualifications

What we're looking for

  • Associate degree or equivalent combination of education and training.
  • Good understanding of clinical trial process across Phases II-IV and ICH GCP, Ability to interact effectively and appropriately with investigative site personnel.
  • Good organizational skills and good attention to detail, with proven ability to handle multiple tasks effectively.
  • Ability to take direction from multiple individuals and set priorities accordingly.
  • Ability to effectively communicate across multiple function groups (clinical team, PM, Director).
  • Demonstrated ability to work independently, as well as part of a team. Utilize problem-solving techniques effectively.
  • Quality-driven in all managed activities.
  • Flexibility and willingness to adapt to rapidly changing environment and learn/perform new functions.

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 and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

#J-18808-Ljbffr

  • Senior Site Activation Specialist

    1 tydzień temu

    Warszawa, Mazovia, Polska TN Poland Pełny etat

    Social network you want to login/join with:Senior Site Activation Specialist (contract Specialist), WarsawClient:IQVIALocation:Warsaw, PolandJob Category:OtherEU work permit required:YesJob Reference:b7fdf3d79111Job Views:24Posted:23.01.2025Expiry Date:09.03.2025Job Description:Country Site ActivationJoin us on our exciting journeyIQVIA's Country Site...

  • Global Site Activation Specialist

    5 dni temu

    Warszawa, Mazovia, Polska Syneos Health, Inc. Pełny etat

    Elevate your career with Syneos Health, Inc. as the Head, European Country Operations!This critical role requires a seasoned professional to oversee key operational functions, including Site ID, Site Activation, CRAs, Line Managers, and Country Heads, ensuring effective resource planning and country-level delivery.You will lead high-performing teams, foster...

  • Site Activation Coordinator

    1 tydzień temu

    Warszawa, Mazovia, Polska TN Poland Pełny etat

    Role SummaryThis is an exciting opportunity to join our team as a Clinical Contract Specialist in Warsaw or Madrid office. You will be responsible for developing and finalizing site agreements and budgets for medical device clinical trials. With a strong focus on collaboration and stakeholder engagement, you will play a crucial role in ensuring successful...

  • Global Site Activation Lead

    6 dni temu

    Warszawa, Mazovia, Polska ICON plc Pełny etat

    Site Activation Leads play a crucial role in advancing clinical trial start-up activities at ICON plc. As a Global Site Activation Lead, you will lead clinical trial start-up activities, develop comprehensive site activation plans, and collaborate with sponsors to deliver high-quality project updates.Your expertise in project management and clinical research...

  • Site Activation Lead

    6 dni temu

    Warszawa, Mazovia, Polska ICON plc Pełny etat

    Site Activation Lead - Warsaw, Poland, HomebasedICON 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 Site Activation Lead to...

  • Global Site Activation Director

    5 dni temu

    Warszawa, Mazovia, Polska Syneos Health, Inc. Pełny etat

    Join Our TeamWe are a leading integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. As a member of our team, you will contribute to the development of Standard Operating Procedures (SOPs),...

  • Site Activation Coordinator, French Speaking

    2 tygodni temu

    Warszawa, Mazovia, Polska IQVIA Pełny etat

    Site Activation CoordinatorFluent French & EnglishBased in Serbia/Bulgaria/South Africa/Croatia/TürkiyeMake an impact on patient healthIQVIA's Global Site Activation Team of 2000 employees drives best-in-class site and customer experience, with industry-leading outcomes.We keep the patient at the forefront; 'Always Impatient for the Patient' and we excel in...

  • Senior Site Activation Coordinator, French Speaking

    2 tygodni temu

    Warszawa, Mazovia, Polska IQVIA Argentina Pełny etat

    Senior Site Activation CoordinatorLanguages: Fluent French & EnglishBased in: Serbia/Bulgaria/Ukraine/South Africa/Croatia/TürkiyeMake an impact on patient healthIQVIA's Global Site Activation Team of 2000 employees drives best in class site and customer experience, with industry leading outcomes.We keep the patient at the forefront; 'Always Impatient for...

  • Country Study Activation Manager

    1 tydzień temu

    Warszawa, Mazovia, Polska Allergan Pełny etat

    About the RoleThe Country Study Start Up Specialist will be responsible for driving and executing all start-up and maintenance related activities and deliverables for assigned studies and sites in their designated country or countries.This role requires a proactive approach to ensure successful and on-time execution of start-up and maintenance activities, as...

  • Global Country Activation Manager

    1 tydzień temu

    Warszawa, Mazovia, Polska GSK Pełny etat

    Job OverviewThe role of the Principal Country & Site Activation Manager (Global Start Up Study Manager) involves overseeing the country and site activation process for clinical trials. This includes developing and delivering a global plan for country and site activation, ensuring that critical study timelines are achieved, and providing troubleshooting...

  • Medical Device Site Specialist

    1 tydzień temu

    Warszawa, Mazovia, Polska TN Poland Pełny etat

    Job OverviewThe role of Clinical Contract Specialist is responsible for developing, negotiating, and finalizing site agreements and budgets for medical device clinical trials. This is an exciting opportunity to join our team in Warsaw or Madrid office and work on projects that make a real difference in people's lives.Key Responsibilities include:Preparing...

  • Consumer Activation Pillar Specialist

    1 tydzień temu

    Warszawa, Mazovia, Polska Procter & Gamble Pełny etat

    Are you looking to take your career to the next level?Position Overview: We are seeking a dynamic and results-driven Consumer Pillar Activation Specialist to join our team. This role is pivotal in driving brand awareness, trial, engagement, and dedication through innovative consumer activation strategies. You will collaborate with cross-functional teams to...

  • Consumer Activation Pillar Specialist

    6 dni temu

    Warszawa, Mazovia, Polska Procter & Gamble Pełny etat

    Job LocationWarsawJob DescriptionAre you looking to take your career to the next level?Position Overview: We are seeking a dynamic and results-driven Consumer Pillar Activation Specialist to join our team. This role is pivotal in driving brand awareness, trial, engagement, and dedication through innovative consumer activation strategies. You will collaborate...

  • Consumer Activation Pillar Specialist

    5 dni temu

    Warszawa, Mazovia, Polska P&G México Pełny etat

    Job LocationWARSAW PLANT & GOJob DescriptionAre you looking to take your career to the next level?Position Overview: We are seeking a dynamic and results-driven Consumer Pillar Activation Specialist to join our team. This role is pivotal in driving brand awareness, trial, engagement, and dedication through innovative consumer activation strategies. You will...

  • Brand Activation Specialist

    1 tydzień temu

    Warszawa, Mazovia, Polska The British American Tobacco Group Pełny etat

    BAT is evolving at pace into a global multi-category business. We are on a mission to decrease the health impact of our industry.To achieve our ambition, we are looking for colleagues who are ready to Be The Change. Come, join us on this journey British American Tobacco Poland has an exciting opportunity for a Tactical Activation Specialist in WarsawWe are...

  • Country and Site Execution Lead

    1 tydzień temu

    Warszawa, Mazovia, Polska GSK Pełny etat

    About the RoleWe are seeking an experienced Principal Country & Site Activation Manager (Global Start Up Study Manager) to join our team. As a member of our Clinical Operations department, you will play a critical role in the success of our clinical trials. Your primary responsibility will be to oversee the country and site activation process, ensuring that...

  • Clinical Research Site Specialist

    1 tydzień temu

    Warszawa, Mazovia, Polska Allergan Pełny etat

    Job DescriptionEnsure successful and on-time execution of start-up and maintenance activities for assigned sites and studies.Establish country/site activation plans and priorities, including risk assessment and mitigation plans with key stakeholders.The ideal candidate will have a strong analytical and critical thinking skillset, with the ability to evaluate...

  • Field Marketing Activation Manager

    2 tygodni temu

    Warszawa, Mazovia, Polska TN Poland Pełny etat

    Field Marketing Activation Manager - Poland, WarsawClient:Location:Warsaw, PolandJob Category:OtherEU work permit required:YesJob Reference:369bac23d5c0Job Views:3Posted:28.03.2025Expiry Date:12.05.2025Job Description:Radisson Hotel Group is one of the world's largest hotel groups with ten distinctive hotel brands, and more than 1,160 hotels in operation and...

  • French Language Specialist

    2 dni temu

    Warszawa, Mazovia, Polska IQVIA Argentina Pełny etat

    About the RoleThis Senior Site Activation Coordinator position is an exciting opportunity for a motivated and experienced professional to join our team.The successful candidate will work closely with the Site Activation Manager and Project Management team to perform tasks at a country level associated with site activation activities.

  • Marketing Activation Manager

    2 dni temu

    Warszawa, Mazovia, Polska TN Poland Pełny etat

    Marketing Opportunity in PolandRadisson Hotel Group is a leading hospitality company serving as a true host and best partner to guests, owners, business partners and talent. Our eight unique hotel brands offer award-winning and exceptional hotel experiences.We are now looking for Marketing Activation Manager - Poland to join our dynamic team here at Radisson...