12 ago - Bardi
Allucent
ppAt AllucentTM, we are dedicated to helping small?medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life?changing therapies to patients in need across the globe.
/p h3Responsibilities /h3 ul liLeads the project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contract /li liCreates and executes project management plans required for project delivery and in accordance with established processes /li liEnsures quality and adherence to the relevant policies, SOPs, and working instructions, GCP and regulatory guidelines.
/li liEstablishes clear communication lines and escalation pathways, communicates with project stakeholders /li liProvides input on study related documents such as the study protocol, CRF, Medical Review/Monitoring plan, and Clinical Study Report /li liEstablishes requirements for and ensures project specific training plan for team activities /li liLeads internal and external meetings, with internal and sponsor teams, including Kick Off Meetings (KOM) and Investigator Meetings based on project scope /li liProvides support for vendor identification, qualification and selection and manages vendors /li liManages vendors and vendor relationships as required for project delivery /li liEnsures effective and efficient resource utilization across projects and programs /li liProduces, maintains and circulates project progress and status reports /li liManages the study budget, including monthly invoicing.
/li liEstablishes project risk management plan with input from client and functional stakeholders and oversees adherence and updates throughout the project lifecycle /li liProactively recognizes and addresses any changes in scope /li liNegotiates and influences internal and external team members in a professional manner and with successful outcomes /li liEffectively solves problems with projects teams by applying strategic thinking and conflict resolution skills /li liEnsures the Trial Master File is kept up to date and inspection ready /li liServes as the primary point of communication between the sponsor and project team /li liLeads by example and encourages team members to develop strong solutions for clinical trial delivery /li liResponsible for oversight of project team delivery and communication with functional managers, including performance feedback /li /ul h3Requirements /h3 ul liMinimum Bachelor's degree in life science, healthcare and/or business degree /li liMinimum 5 years of relevant work experience /li liMinimum 5 years of experience in drug development and/or clinical research, with at least 3 years of clinical trial project management experience /li liPreference for candidates with CRA experience /li liExpert knowledge of ICH?GCP(R2), data and patient privacy practices, and applicable (local) regulatory requirements /li liDemonstrates strong financial acumen,
administrative excellence and analytical skills /li liExperience managing all phases of the full?service clinical trial delivery lifecycle (Start?up, Maintenance, Close?out) /li liExcellent written and verbal communication, planning, critical thinking and organizational skills, including command of English language /li liRepresentative, outgoing and client focused /li liAbility to work effectively in a fast?paced challenging environment with a growing company /li liProficiency with various applications including, but not limited to, Microsoft Word, Excel, and PowerPoint required /li liStrong presentation skills /li liFosters learning and the advancement and development of others /li liDependable and able to take action to quickly to address urgent needs /li liProactive and solution oriented /li liWillingly takes ownership and drives positive, collaborative results with the project team /li liExercises good judgement with defined procedures and policies to determine appropriate action /li /ul h3Benefits /h3 ul liComprehensive benefits package per location /li liCompetitive salaries per location /li liDepartmental Study/Training Budget for furthering professional development /li liFlexible Working hours (within reason) /li liOpportunity for remote/office* working depending on location /li liLeadership and mentoring opportunities /li liParticipation in our Buddy Program as a new or existing employee /li liInternal growth opportunities and career progression /li liFinancially rewarding internal employee referral program /li liAccess to online soft?skills and technical training via ADP and internal platforms /li /ul /p #J-*****-Ljbffr
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