Job Number: 411175
Support the development of operational plans for clinical deliverable
Contribute to the development and review of Clinical Development Plan (CDP) with focus on operational aspects Contribute/support the Operational CDP (O-CDP) Create trial concept sheet.
Support development of Program Operational Plans (e.g. budget package, project-level allocation, program-level outsourcing strategy, monitoring committees, etc).
Support the Clinical Science Unit (CSU) operationally and scientifically by ensuring development of program quality standards (e.g. collation of synopsis/protocols/CDP reviews, provide scientific/medical input, advisory boards, education activities). Support development and implementation of disease/program standards.
Support Medical Lead with the development of program level documents, including clinical sections of regulatory documents (e.g. Investigators' Brochures, briefing books, submission dossier, and responses to Health Authorities questions).
Responsible for execution of assigned clinical deliverable
Lead the clinical trial protocol development process by independently translating the Clinical Development Plan strategy and approved trial concept sheets into efficient, high quality, executable clinical protocols and related documents:
Seek external (e.g. KoL, regulatory authorities, patients associations) and internal (e.g. CSU, CPO Medical Advisors) medical/scientific input Drive science by incorporation of innovative designs Obtain approval from internal review boards In collaboration with Trial Statistician, develop Reporting and Analysis Planning (RAP) modules Responsible to drive development and implementation of relevant data capture toolsent Manage committee meetings/reviews timelines; and provide regular updates to Safety Management Team and other clinical boards.
Responsible for the ongoing review of clinical trial data Supports GTL to prepare database lock; and perform data reconciliation.
Support Medical Lead/BSL to identify any safety trends; and as needed, reports on trial data to safety and clinical boards (e.g. SMT, GCT, GPT).
In collaboration with Medical Lead, responsible for final analysis and interpretation of results.
May serve on or lead global process improvement work streams or act as Subject Matter Experts for training or SOP.
Timely delivery of quality documents to support the Clinical Development Plan (e.g. concept sheets, executable synopses); as well as clinical component of regulatory documents Execution of the trial protocol and related documents in collaboration with GTL, in compliance with international and local regulations and our clientsinternal standards Demonstrates excellent scientific writing skills to enable the development of quality clinical protocols, trial reporting, and regulatory documents (no avoidable amendments) Submission of quality documents at Final Protocol Package (e.g. protocol, ICF, clinical sections of the CTA) Applies effective clinical research methodology, including trail design/analyses, efficacy endpoints, safety assessments across disease area and development phases Data cleaning & review
Skills; 4 years technical and operational experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organisation.
Manage several trials in parallel with multidisciplinary trial teams in a matrix organization Strong interpersonal skills Ability to work under pressure Excellent negotiation and conflict resolution skills Resolve issues with minimal supervision and understand when to escalate Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process.
Demonstrates excellent scientific writing skills Knowledge of the assigned therapy area is desired, with the capability to interpret, discuss and represent trial or program level data.
Demonstrates knowledge and application of statistical analysis methodology and can identify trends and interpret / report data effectively Keywords
Advanced degree (or clinically relevant degree) in life sciences/healthcare is required.
PharmD, PhD preferable.
Interested candidates please send resume in Word format to email@example.com Please reference job code 411175 when responding to this ad.