Specialist, Clinical Trial Management

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7arkl3

ppThe Specialist, Clinical Operations supports the planning, execution, and administration of clinical trials.
This position is responsible for administrative and coordination tasks and will have increasing Study Team Lead (STL) accountabilities with oversight of the STL.
The position offers the opportunity to increase responsibilities in clinical trial tasks and may also be responsible for additional assignments such as clinical systems development.
The position requires adaptability and the capacity to 'own' tasks, problem solve and to see activities through to conclusion.
/ph3Responsibilities /h3ulliInteract directly with the Clinical Operations team (e.g., STLs, CBO, managers), other functional leads that are members of the Clinical Study Team, CRO and other vendors to provide support in study-specific tasks and the overall management of clinical trials.
/liliSupport Operational Team Leaders (OTLs) and STLs, and, as requested by the OTL or STL, other study team members.
Specific responsibilities include: /liliMaintain and manage data entry into AL designated study systems to fulfill study requirements and be responsible for requests for access to study systems and deactivation of system users.
/liliCoordinate materials (PowerPoint presentations, templates, outstanding essential document listing, etc.) as needed for internal and external meetings.
/liliMaintain and update study team and vendor contact information.
/liliAssist in the planning, organizing and execution of study-specific meetings and write and distribute agendas, minutes and regular updates.
/liliDrafting, reviewing, formatting and finalizing study-related templates, plans and manuals.
/liliSupport the invoice process if required.
/liliVendor management (if applicable) and tracking deliverables.




/liliManage the maintenance of clinical trial insurance.
/liliAssist with questions, issues or requests from the CRO/study team and route to the appropriate individual within the organization for resolution.
/liliTMF oversight along with review of Trial Master File (TMF) Plan, contribute to TMF reviews, support the study team with essential document collection and upload to the TMF.
Act as escalation point for document classification if required and any other CST support of the TMF.
/liliDevelop and maintain study-related trackers as required.
May analyze or update data associated with specific trackers.
/liliProvide general administrative and operation support to the CST.
/liliContributing to Clinical Operation department initiatives.
/liliOther duties as assigned to support STLs and OTLs – specific STL accountabilities to be assigned by STL and overseen.
/liliUnderstand the legal and compliance environment and drive collaboration with the Legal and Compliance team /liliMentor Specialists as needed.
/liliDrive the spirit of "ONE Team" across all functions by supporting a team approach to focus on our patients and customers as our top priorities.
/li /ulh3Qualifications /h3ulli5 plus years' experience supporting life sciences with a general understanding of clinical trials.




/lili3 plus years of Pharmaceutical or CRO experience in a support role.
/liliBachelor's degree, or equivalent, in a biomedical, life science or related field of study, preferred.
/liliIncreasing knowledge of GCP, ICH guidelines and EMA/CHMP regulations / FDA regulations and guidelines.
/liliProactive, self-starter who possesses good multi-tasking and communication skills, both oral and written.
/liliDemonstrates the ability to work effectively in environments where processes are still developing, using initiative and sound judgement to drive tasks forward /liliDemonstrated CTA expertise; keen understanding of all aspects of Clinical Operations /liliMust possess a professional, "customer-service" demeanor and effective communication capabilities for collaboration with others in a cross-functional matrix team.
/liliGood problem-solving skills, a strong sense of urgency, keen attention to detail, ability to work independently and be able to effectively manage multiple priorities in an environment under time and resource pressures.
/liliExcellent proficiency in Microsoft Word, Excel, and PowerPoint, and some knowledge of Veeva systems.
/liliAbility to think strategically in order to improve current processes.
/liliStrong verbal and written communications skills /liliLearning agility and 'scalability' to take on increasing responsibility as Alfasigma grows /liliConsistent demonstration and embodiment of company core beliefs /li /ulpThe compensation range indicated in this job posting represents an estimated average range for the position.
The final remuneration will be determined based on the selected candidate's experience, skills, and qualifications, in accordance with applicable EU pay transparency and pay equity requirements /p /p #J-*****-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7arkl3