Array ( [id] => 1057 [azienda_id] => 172 [lauree] => {null} [settore] => [ruolo] => [inserimento] => [time_c] => 0 [last_mod] => 1700228084 [title] => Project Specialist [body] =>

Location: Home-based Italy (preferred big and well-connected cities, usually Milan or Rome)
Work mode: Ability to travel if necessary preferred (approximately 5%) 
Contract: Permanent

Job summary:
The Project Specialist performs administrative and supportive activities assigned by the Project Lead to ensure the contracted services and expectations are carried out by the project team in accordance with executed contracts and the customers’ expectations.

Job responsabilities:

• Set-up, maintain and/or close out project files and study information ((e.g., regulatory documents, Trial Master File (TMF), enrollment, Adverse Events (AEs)/Serious Adverse Events (SAEs), site supplies, Institutional Review Board re-approvals, data queries) on a variety of databases and systems. 
• Attends, participates, prepares and distributes meeting minutes and action items for both internal and external meetings (sponsor, trusted process, functional, investigator meetings). Follows up with team members on action items to closure.
• Maintains timely and effective communication among team members and site staff. Keeps Project Leadership and Clinical Research Associates (CRAs) fully appraised of sites and study status. May contact site staff as needed for critical information.
• Provide administrative support to Project Leads and functional leads.
• Ensure all study documents are archived based on the appropriate guidelines and policy. 
• Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues.

What we’re looking for:

• Associates Degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field or equivalent combination of education and experience 
• Knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements
• Strong organizational skills
• Ability to manage time and work independently
• High proficiency with full MS Office Applications
• Strong communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade 
• High level of competence in English language

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Array ( [id] => 1056 [azienda_id] => 172 [lauree] => {null} [settore] => [ruolo] => [inserimento] => [time_c] => 0 [last_mod] => 1700228071 [title] => Clinical Research Associate (CRA) [body] =>

Location: Home-based Italy (preferred big and well-connected cities)
Work mode: Ability to manage required travel of up to 75% on a regular basis
Contract: Permanent

Job summary:
The Clinical Research Associate I (CRA I) will perform monitoring and site management activities for Phase I-IV clinical research projects to assess the progress of clinical projects at assigned investigative/physician sites (either on site or remotely) and to ensure clinical projects are conducted, recorded, and reported in accordance with the protocol, Company and Sponsor standard operating procedures (SOPs), ICH-GCP and/or all applicable local and federal regulatory requirements. Requires guidance and oversight, while developing an understanding of the drug development and commercialization process.

Job responsabilities:

➤ Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiological Practices (GPP) and protocol compliance. Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and with guidance develops action plans. Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.

➤ Verifies the process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate. Demonstrates diligence in protecting the confidentiality of each subject/patient. Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues.

➤ For the Clinical Monitoring/Site Management Plan (CMP/SMP):

• Assesses site processes.
• Conducts Source Document Review of appropriate site source documents and medical records.
• Verifies required clinical data entered in the case report form (CRF) is accurate and complete.
• Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines.
• Utilizes available hardware and software to support the effective conduct of the clinical project data review and capture.
• Verifies site compliance with electronic data capture requirements.

➤ May perform investigational product (IP) inventory, reconciliation and reviews storage and security. Verifies the IP has been dispensed and administered to subjects/patients according to the protocol. Verifies issues or risks associated with blinded or randomized information related to IP. Applies knowledge of GCP/local regulations and organizational procedures to ensure IP is appropriately (re)labelled, imported and released/returned. 

➤ Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles contents of the ISF with the Trial Master File (TMF). Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.

➤ Documents activities via confirmation letters, follow-up letters, trip reports, communication logs, and other required project documents as per SOPs and Clinical Monitoring Plan/Site Management Plan. Supports subject/patient recruitment, retention and awareness strategies. Enters data into tracking systems as required to track all observations, ongoing status and assigned action items to resolution. 

➤ For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met. Must be able to quickly adapt, with the oversight of the Lead CRA, to changing priorities to achieve goals / targets. 

➤ May act as primary liaison with project site personnel, or in collaboration with another CRA or Central Monitoring Associate (CMA). Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements. 

➤ Prepares for and attends Investigator Meetings and/or sponsor face to face meetings. Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements. 

➤ Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.

➤ For Real World Late Phase, the CRA I will use the business card title of Site Management Associate I. Additional responsibilities include:

• Site support throughout the study lifecycle from site identification through close-out
• Knowledge of local requirements for real world late phase study designs
• Chart Abstraction activities and data collection
• Collaboration with Sponsor affiliates, medical science liaisons and local country staff

What we’re looking for:

➤ CRA certification according to Ministerial Decree 15 Nov 2011
➤ Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
➤ Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
➤ Must demonstrate good computer skills and be able to embrace new technologies
➤ Excellent communication, presentation and interpersonal skills

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Array ( [id] => 1055 [azienda_id] => 172 [lauree] => {57} [settore] => [ruolo] => [inserimento] => [time_c] => 0 [last_mod] => 1700228057 [title] => Site Contract Specialist [body] =>

Location: Home-based Italy (preferred big and well-connected cities, usually Milan or Rome)
Contract: Permanent

Job summary:
Administers and negotiates site contracts that support projects within Clinical Operations on a global scale, with oversight from the SSU Country Manager. Ensures site contract documentation is in compliance with sponsor and Company requirements. Works with internal and external team members to implement solutions for project and/or individual site contract related problems. Establishes strong working relationships with customer, internal project teams and sites. Ensure all relevant documents are submitted to the Trial Master File (TMF) as per Company SOP/Sponsor requirements.

Job responsabilities:

• Administers all contract management processes, including coordination with relevant protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level. 
• Supports the SSUL 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 SSUL lead with Sponsor until resolution of issues. 
• Assists with quality control and arranges execution of CTAs as well as archival of documents into repositories and capture of metadata.
• Assists in the reviews of contracts for completeness and accuracy, and ensures that corrections are appropriately made and documented.
• Assists SSU leads, Managers or other site contracts staff with the active project management of ongoing contract issues; performs follow-up on all outstanding contract issues.
• Assists in providing and generating (amended) contract and/or budget documents as necessary, preparing contract management documentation for projects, and streamlining the contract/proposal or internal processes; initiates and introduces creative ideas and solutions.
• Works within the forecasted country/site contracting timelines, ensures they are complied with and tracks milestone progress in agreed upon SSU tracking system in real time.
• Collaborates with internal and external legal, finance, and clinical operations departments including communicating and explaining legal and budgetary issues for contract management tasks and issues.
• Facilitates the execution of contracts by company signatories.
• Supports the maintenance of contract templates and site specific files and databases.
• Serves as communication liaison between site contracts staff and internal and external customers. Provides functional guidance and keeps internal and external teams aware of all contract statuses or pending issues. Prepares correspondence as necessary. 
• 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.

What we’re looking for:

• BA/BS degree in related field or equivalent combination of education and experience
• Clinical research, contracts, or related experience that includes working in a team-oriented environment preferred
• Strong skills in Microsoft Office Suite, email, and voicemail
• Strong organizational, presentation, documentation, and interpersonal skills
• Ability to handle multiple tasks to meet deadlines in a dynamic environment
• 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
• Strong computer skills, including Word, Excel

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Array ( [id] => 1054 [azienda_id] => 172 [lauree] => {null} [settore] => [ruolo] => [inserimento] => [time_c] => 0 [last_mod] => 1700228043 [title] => Clinical Operations Specialist [body] =>

Location: Home-based Italy (preferred big and well-connected cities, usually Milan or Rome)
Work mode: Minimal travel up to 25% may be required
Contract: Permanent

Job summary:
The position is responsible for providing clerical, administrative, and technical administrative support to one or more business units or clients within Clinical Operations.

Job responsabilities:

• Responsible for performing activities in compliance with applicable Corporate and Clinical Operations Policies, Standard Operating Procedures and Work Instructions.
• Assists Clinical Monitoring staff with site management activities, including serving as a Sponsor representative for sites on assigned studies, and communicating with sites to ensure compliance with protocol requirements, study procedures and relevant guidelines.
• Creates and assists with maintenance of Trial Master File (TMF) and project files, including participation in file audits.
• Prepares and maintains site manuals, reference tools and other documents.
• Maintains, updates, and inputs clinical tracking information into databases.
• Tracks incoming and outgoing clinical and regulatory documents and updates for investigator sites, studies, project team, or client.
• Manages shared mailbox, processes site requests and routes correspondence appropriately.
• Coordinates the ordering, packaging, shipping and tracking of site supplies and materials.
• Assists with coordination of team meetings, attends meetings and prepares accurate meeting minutes and action items.
• May handle receipt, tracking and disposition of Case Report Forms and Queries.
• Maintains overall awareness in the field of clinical research by completing all necessary and assigned training.

What we’re looking for:

• High School diploma or equivalent
• Good communication and interpersonal skills
• Ability to embrace new technologies

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Array ( [id] => 1053 [azienda_id] => 172 [lauree] => {null} [settore] => [ruolo] => [inserimento] => [time_c] => 0 [last_mod] => 1700228029 [title] => Site Activation Specialist [body] =>

Location: Home-based Italy (preferred big and well-connected cities, usually Milan or Rome)
Work mode: Minimal travel up to 25% may be required
Contract: Permanent

Job summary:
Performs assigned activities within the country that lead to start-up of investigative sites in all phases of clinical trials. Responsible for the delivery, with oversight from the Line Manager in one or more of the following functional areas: investigator site contracts, ethics and regulatory submissions, collection and review of essential documents required for site initiation and site activation activities. Ensures local activities are undertaken in accordance with agreed timelines, allocated budgets, and required quality standards. Ensures an efficient start-up process on assigned studies. May act as main contact with Regulatory Authorities (RA) and Central/Regional Ethics Committees (ECs) under the supervision of the Project Lead (PL) or Site Activation Manager (SAM) as appropriate, may directly interact with Customers regarding requirements from RA or other local regulatory party.

Job responsabilities:

• 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 startup advisor (CSA) and SAM. May serve as a point of contact for the SAM/PM (or designee) during startup 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.
• 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/SAM to ensure that the appropriate sites are selected for individual studies based on the requirements of the clinical trial.
• May be asked to perform: Local Investigator Contract and Budget Negotiator – Supports the SAM 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 SAM 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.

What we’re looking for:

• Associate’s 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.
• Good English skills.
• Strong computer skills, including Word, Excel, PowerPoint, Publisher.

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