Job Title: Clinical Trial Leader 1
Location: Cambridge, MA
Duration: 3 Month Temp to Perm
Job Description:
Department: Translational Clinical Oncology
Accountable for all aspects of assigned TCO clinical trials (Phase I/II) including leading Clinical Trial
Team(s) (CTT).
Major Accountabilities
1.Lead the clinical protocol development process in collaboration with the Clinical Program Leader (CPL): responsible author for clinical protocols, amendments and related documents; contribute to the medical/scientific input given for the development of trial-related documents and processes which reside in other line functions; obtain approval from internal review boards. Collaborate with the Medical Directors of the Client local organizations (CPOs) and investigators to ensure their feedback is adequately integrated into protocol.
2. Contribute to the development of clinical sections of regulatory documents like Investigators’ Brochures, briefing books, safety updates,
IND/NDA submission documents, responses to Health Authorities questions.
3. Investigator/site relationship management is vital; must develop effective working relationship with key investigators in assigned therapy area to optimize scientific quality/innovation of clinical study design, execution, reporting and publication. Contribute to trial-related advisory boards.
Lead investigators meetings. Lead protocol training meetings and support CPOs in the conduct of regional meetings. Accountable for all internal clinical meetings related to the clinical trial(s).
4. Lead and matrix manage the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, and resource requirements; speaks up against unrealistic timelines. Energizes CTT to adhere to global performance and quality standards: chair CTT meetings, report study progress and issues with their resolution plan. Engages the input of line functions at the appropriate time. Leads trial level interactions with Global Monitoring Operations (GMO) and other relevant functions including Integrated Medical Safety and Drug Supply Management.
5 In collaboration with the CPL lead the clinical trial data ongoing medical/scientific review, final analysis and interpretation including the development of clinical trial reports, publications and internal/external presentations.
6. Prepare and run dose escalation meetings with investigators. Coordinate the real time availability of quality clinical trial data, including safety, efficacy, pharmacokinetic, imaging and biomarker data, to provide consolidated information for dose escalation meetings with investigators.
7. Forecast trial resources needs (external costs): accountable for the development, management and tracking of trial budget working closely with
CRO Management, with Clinical Trial Budget Managers and TCO Global Program Managers. Accountable for accuracy of trial information in all trial databases and tracking systems.
8. Sits on early Program Team (EPT) to contribute to program strategy.
9. Ensure that program specific standards (e.g., CRFs, outsourcing specifications including imaging, biomarkers PK, data monitoring, validation plans and data transfer specifications) are applied to the clinical trial, where applicable.
10. Develop clinical outsourcing specifications to facilitate bid templates and selection of CROs and other 3rd parties including central lab and imaging vendors; manage interface with external vendors in cooperation with the CRO Management Department as well as with the Assay
Research Lab. This also includes the set-up, logistics, documentation and clinical supplies needed
11. For TCO trials, function as local trial leader (LTL), supported by the CPA, for all US activities including working closely with US GMO for all study start-up activities including regulatory documents, budget, contract agreements and all activities pertaining to updates as dictated by amendments.
As the LTL, be the primary contact for US sites for clinical conduct of the trial.
12. CTLs based in TCO Shanghai, support local CTA submission including validation of translation of protocols, amendments, ICFs, IBs etc. for TCO trials with sites in China, supported by the CPA.
13. May participate in the on-boarding and mentoring of new TCO staff.
14. Contribute to the implementation of best practices and standards for trial management, including sharing lessons learned.
Key Performance Indicators
Planning, executing and closing of early phase trials on time and within budget
Adherence of GCP/ICH to ensure high quality trial conduct
Ongoing data review to promote trial decisions and strategic planning
Job Dimensions
Financial responsibility: Responsible for financial/resource decisions within scope of assigned authority.
Impact the organization: Well managed and effective trial team(s) resulting in the timely delivery of high quality clinical trial data and data analysis which enables strategic decisions within the clinical program.
seen as a credible, ethical and preferred partner by key investigators in Oncology.
Job details are sourced from the employer's original posting.
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