Execute deliverables of all aspects of assigned clinical studies,
including,
but not limited to,
investigator selection,
vendor selection,
study startup activities and site initiation,
preparation of study documentation,
including protocols,
consent documents,
laboratory manuals,
biospecimen tracking,
clinical data oversight,
and closeout activities.
Manage,
lead and mentor clinical study support staff (CRAs,
CTAs) as needed.
Participate in soliciting and reviewing vendor/clinical site proposals and budgets,
and subsequent selection,
contracting,
invoicing,
and management of study vendors and/or CRO(s) as required.
Collaborate with other clinical trial managers on the team to determine lessons learned and implement best practices across all clinical programs.
Provide regular updates of study progress to key internal stakeholders.
Proactively identify and resolve issues that arise during study conduct;
manage escalation of study-related issues,
as needed.
Identify barriers to timely and successful study execution and propose solutions.
Provide monitoring oversight by reviewing monitoring schedules,
metrics,
and reports.
May oversee or manage clinical documentation and monitoring reports.
May be responsible for conducting on-site initiation visits and interim monitoring visits and creating applicable documentation.
Contribute to clinical study feasibility and timeline assessments.
Ensure compliance with all applicable regulatory requirements by monitoring compliance with all company standard operating procedures (SOPs),
FDA regulations,
GCP guidance,
and applicable international regulations concerning clinical activities.
Establish and maintain effective working relationships with coworkers,
managers,
and clients/customers.

Requirements

BA/BS degree and at least six years’ of clinical trial management industry experience (biopharma,
medical device,
or closely related field).
Advanced degree preferred,
additional coursework in clinical trial planning and execution.
A strong working knowledge of clinical trial operations,
clinical study design,
study enrollment planning,
strategies and management,
and site monitoring.
Strong experience in the management of CROs and other vendors/suppliers.
Working knowledge of the Medical Device Regulations,
CFR Parts 11,
50,
54,
56 and 812 and ICH GCP guidelines.
Ability to work independently as well as to inspire and motivate the team.
Proven project management skills and study leadership ability.
Excellent problem-solving ability,
verbal,
and written communication skills.

Benefits

You will also be eligible to receive equity
cash bonuses
a full range of medical
financial
and other benefits depending on the position offered

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical trial managementclinical study designstudy enrollment planningsite monitoringvendor managementclinical data oversightbiospecimen trackingregulatory complianceproject managementclinical documentation

Soft Skills

leadershipmentoringproblem-solvingcommunicationteam motivationindependencecollaborationstakeholder managementissue resolutionrelationship building