Clinical Trial Head – Oncology Job at Metuchen, NJ
Our major pharmaceutical client is looking for a Clinical Trial Head for a 6+ month position in Morris County, NJ.
Requirements:
Minimum 4 years technical, operational and managerial experience in planning, executing, reporting and publishing clinical studies in a pharmaceutical company or contract research organisation.
Proven ability to work independently, to lead a multidisciplinary trial team in a complex matrix environment (including remote).
Experience in developing effective relationships with key investigators.
Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, regulatory processes, and global clinical development process.
Advanced knowledge of the Oncology and/or Hematology is preferable.
Description:
1. Accountable for the writing of clinical protocols and related documents in collaboration with the CPL, CIL, and/or MSE,: lead the clinical trial protocol development process; 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 and Advisors of the major internal local medical
organizations to ensure country feedback is adequately integrated into protocol.
2. Participate in development of 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 to support local medical organizations in the conduct of regional meetings. Accountable for all internal meetings related to the clinical
trial.
3. Lead and matrix manage the global multidisciplinary CTT to ensure all trial deliverables are met according to timelines, budget, quality standards and operational procedures: chair CTT
meetings, report study progress and issues with their resolution plan to International Clinical Teams; lead trial level interactions with Oncology Development Operations and other relevant
functions including Drug Supply Management and local medical organizations.
4. In collaboration with the CPL, CIL, and/or MSE,, 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.
5. Develop clinical outsourcing specifications to facilitate bid templates and selection of CROs; manage interface with CROs in cooperation with the Business Relationship Manager in the
Contract Management Department.
6. Forecast trial resources needs (headcount and external costs): accountable for the development, management and tracking of trial budget working closely with the appropriate
groups in Oncology (e.g. CRO management, POM). Accountable for accuracy of trial information in all trial databases and tracking systems. Assess resource needs with program
and TA management to ensure appropriate line function allocation.
7. In collaboration with the Lead CTH, assign short to mid-term responsibilities to CM who assist in the planning, conduct and reporting of clinical trials; independently manage the day-to-day
interactions with the CMs.
8. Accountable for overall management of CMs. Identify training needs to foster high level of performance, support career development through quality development plans. Proactively manage performances issues. Establish annual objectives according to OGD priorities.
9. 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.
10. Accountable that program specific standards (e.g., CRFs, outsourcing specifications, data monitoring and validation plans) are developed and applied across all trials to ensure consistency of clinical dossier.
11. Responsible for implementation of best practices and standards for trial management within the TA, including sharing lessons learned.
12. Participate in the on-boarding, and training of new staff. Mentor TA staff. May serve as faculty member for OGD training programs.
Qualified candidates should please send a MS Word copy of their resume to manisha@sunrisesys.com. PLEASE INCLUDE THE JOB REF # “ClinTrialHead-EHNJ” IN THE SUBJECT LINE!
ExperienceContact Information:
Sunrise Systems Inc
PO BOX 4647
Metuchen, NJ 08840
Contact: Manisha Subramanian
Phone: 732-603-2200
Fax: 732-603-2208