Clinical Scientist

USWM, LLC•Philadelphia, PA

6h•$120,000 - $165,000•Remote

About The Position

The Clinical Scientist role is a global role, based in the US. The role provides scientific and operational input and oversight, as well as leadership and management of cross-functional execution of clinical trials. The Clinical Scientist will be responsible for leading global clinical trial delivery including the planning, management and reporting of trials in accordance with company plans/objectives, GCP, local country requirements and company standard operating procedures. This includes leading cross-functional Study Conduct Teams, writing and/or reviewing protocols and other study related documents, country/site selection, start up, study conduct and oversight, data review, and study close-out, for one or more clinical trials.

Requirements

Minimum of a BA/BS in Life Sciences Degree
Previous leadership in a matrix environment
4-7+ years of industry-sponsored clinical trial management experience.
Strong knowledge of clinical operations and the regulatory process - experience independently leading/managing multiple clinical trials
EDC experience including trial management, data review, issuing and resolving queries, CRF design/review/ approval
Experience with clinical protocol development and/or regulatory submissions and management

Responsibilities

Support study design, translate scientific imperative into operational delivery of trials.
Review and/or writing of study concept, protocol, study plans, CSRs, publications
Lead the cross-functional Study Conduct Team; drive operational delivery and facilitate issue resolution
Plan and maintain timelines, conduct study feasibility, risk assessment/management and contingency planning.
Ensure timelines are communicated to all team members assigned to the study (including vendors)
Develop and maintain effective relationships with clinical sites and KOLs globally.
Lead Site/Investigator meetings and represent study team at industry conferences as needed.
Provide guidance on protocol and procedures in the development of eCRF design.
Liaise with monitors to identify trends on data management issues/ICF issues/quality issues/ investigator site file (ISF) issues/site staff issues to develop solutions.
Review clinical trial data; monitor data quality and ensure appropriate quality measures are in place to identify any issues with data metrics and data integrity.
Support and review of study and site budgets, including vendors contracts, POs and invoice approval.
Study specific vendor oversight, interaction and coordination in conjunction with cross-functional team members, as appropriate.
Liaise with treatment operations, logistics and manufacturing teams to ensure subject treatment co-ordination.
Ensure cross-functional maintenance of TMF and inspection readiness activities are completed.
Proactive stakeholder management and communication of progress, risks and issues.
May provide mentoring of other members of CDO/company as applicable.
Contribute to process improvement initiatives including SOP writing/revision, Guidance Documents, workstreams, etc.