Senior Project Assistant, Early Phase

2 weeks ago

Romania Indero (formerly Innovaderm) Full time €25,000 - €40,000 per year
The Senior Project Assistant works with Project Managers, Project Coordinators and Clinical Research Associates (CRA) at many stages during clinical studies. Works independently to coordinate and manage study deliverables and administrative tasks, as required by the project team.

More specifically, the Senior Project Assistant, Early Phase must:
  • Participates and supports the project team for assigned studies with administrative tasks
  • Assists with maintenance of projects within Smartsheet and CTMS if applicable (i.e., trackers, contacts, etc.)
  • Verification and tracking of vendor and site invoices
  • Reconciles project team training against project specific training matrix
  • Monthly reconciliation of the project specific training matrix
  • Export and send documents to the eTMF, according to the eTMF plan
  • Follow-ups with team members for completion of their project specific training
  • Assists with initiating and maintaining study files (eTMF)
  • Filing of email correspondences in eTMF
  • Support with system accesses: creating, management of requests and revoking
  • Supports the project coordinators with tracking, uploading and entering metadata for the site regulatory documents
  • Supports the project coordinator to resolve the eTMF queries
  • Assist with tracking and review of the site close-out documents
  • May be assigned to the management of the study specific training in SOLABS
  • Update enrollment tracker (screened, randomized, screen failed) for assigned studies
  • Download site visit reports and site letters from CTMS and send for upload to eTMF
  • May assists with project tracking activities and status reports preparation
  • May support with sending and/or collecting documents to sites
  • Assist with the periodic review of study files, training documentation and CTMS for completeness (e.g. eTMF, project and systems training completion) and verify that actions items and protocol deviations have been pushed from the site visit reports to the CTMS library
  • Prepare site information packages for CRA (e.g. required site follow-up from central monitoring activities, action items, protocol deviations, eTMF completeness, etc) in preparation for their upcoming monitoring visits
  • Assist Clinical Research Associate (CRA), Site Visit Report Reviewer (SVRR), Central Monitors (CM) and other Clinical Operations team members with generating reports from clinical systems such as the EDC, CTMS, Smartsheet and TMF (e.g. reports on action items, protocol deviations, data entry and query status, source data verification status, etc…)
  • Ensure CRA site assignments are up to date and accurate in CTMS
  • Assist with the tracking of visits, site visit report compliance, and study documents
  • May assist in the preparation, distribution, and filing of clinical documents and study supplies
  • May support other groups within the Early Phase Department with various administrative tasks
  • Participates in various administrative tasks, as required, to accomplish the goals of the project and the needs of the project team

Requirements:
  • Experience in clinical research and in biotechnology, pharmaceutical, and/or CRO industry is an asset.
  • Proficient in English (oral and written)
  • Good knowledge and competency in Word, Excel, and PowerPoint.
  • Ability to prioritize multiple assignments to meet deadlines.
  • Attention to detail and accuracy in work.
  • Quick learner, good adaptability and versatile.
  • Strong organizational, communication, problem-solving, time management and multi-tasking skills.
  • Ability to work in a fast-paced evolving and global environment and establish good relationships with colleagues,
  • Strong organizational, communication, problem-solving and multi-tasking skills

Our company:

The work environment

At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.

In this position, you will be eligible for the following perks:
  • Flexible work schedule
  • Home-based position
  • Ongoing learning and development

About Indero

A Global Clinical Leader In Dermatology

Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.

Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years' experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Romania.

  • Associate Project Manager, Early Phase

    2 weeks ago

    Romania Indero (formerly Innovaderm) Full time €60,000 - €80,000 per year

    The Associate Project Manager, Early Phase and Translational Research (APM, EPTR) ensures the successful initiation, planning, execution, monitoring, controlling and closure of assigned Early Phase clinical research projects. In addition, the APM, EPTR is responsible for the operational management and oversight of the clinical investigative sites as well as...

  • Medical Director/Senior Medical Director

    2 weeks ago

    Remote, Romania Precision for Medicine Full time €90,000 - €120,000 per year

    Precision for Medicine is hiring a Medical Director/Senior Medical Director – Hematology/Oncology to join our global team, candidates can work remotely in any of the following locations: Poland, Hungary, Romania, Serbia or Slovakia. Position Summary: The Medical Director serves as the project physician and provides medical and scientific expertise to...

  • Trial Vendor Senior Manager

    2 weeks ago

    Romania 1596 Parexel International Romania SRL Full time €40,000 - €60,000 per year

    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...

  • Clinical Research Associate II/Senior Clinical Research Associate

    2 weeks ago

    Remote, Romania Precision for Medicine Full time $50,000 - $80,000 per year

    Precision for Medicine is not your typical CRO. We are passionate about cultivating our culture and are proud to share extremely high CRA retention rates compared to industry averages. CRAs join us, love their jobs, and stay because of the amazing people and enjoyable quality of life. You will have a lower than average number of protocols, setting you up to...

  • Senior Brand and Market Researcher

    2 weeks ago

    Romania Superbet Full time €60,000 - €80,000 per year

    We're looking for a Senior Brand and Market Researcher to join the Customer Insights & Research team at Superbet. In this pivotal role, you'll play a key part in shaping our brand and market research efforts by executing high-impact studies and translating complex data into clear, actionable insights. Your research will help guide strategic decisions across...

  • Senior Project Manager

    2 weeks ago

    Romania Ameresco Full time €90,000 - €120,000 per year

    Ameresco, Inc. (NYSE:AMRC) is a leading energy solutions provider dedicated to helping customers reduce costs, enhance resilience, and decarbonize to net zero in the global energy transition. We are a trusted, full-service partner to public sector and government entities, K-12 schools, higher education, utilities, and healthcare customers across the U.S.,...

  • Accounts Payable Specialist EMEA

    2 weeks ago

    Romania Remofirst Full time €104,000 - €130,878 per year

    RemoFirst empowers employers to be free from geographical boundaries when accessing talent, allowing employees to pursue opportunities wherever they may exist. We are on a mission to be the FIRST to truly revolutionize the industry and be a generational company.Our platform offers a full-range people management tool, employee benefits like health insurance,...

  • Senior Project Manager

    1 week ago

    Romania Globant Full time €104,000 - €130,878 per year

    At Globant, we are working to make the world a better place, one step at a time. We enhance business development and enterprise solutions to prepare them for a digital future. With a diverse and talented team present in more than 30 countries, we are strategic partners to leading global companies in their business process...

  • Senior Functional QA Engineer

    2 weeks ago

    Romania Luxoft Full time €60,000 - €80,000 per year

    Project descriptionReporting to the Senior QA Manager, the Senior QA engineer creates and executes product test plans to ensure software products meet design specifications and product quality standards. Assists Development team with process improvements to improve product qualityResponsibilitiesCreate test cases from product specifications.Executes test...

  • Senior Information Technology Project Manager

    2 weeks ago

    Romania Dhara Consulting Group Full time €60,000 - €80,000 per year

    TodaySecretUnspecifiedUnspecifiedManagementMK, Romania (ON-SITE/OFFICE)Overview**CONTINGENT UPON CONTRACT AWARD** SOSi is seeking a highly qualified Senior Project Manager to support US Army requirements in the Europe & Africa Area of Responsibility (AOR).Essential Job Duties Plans, initiates, and manages information technology (IT) projects to support...