FSP - Clinical Trial Manager

About Parexel FSP

We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.

Position Purpose: The Senior Executive Clinical Recruiter is responsible for: Achieving hiring objectives by recruiting and evaluating candidates for open job orders Primary Duties:

• Acting as Protocol Lead on one or more clinical trials and serving as the main point of contact for

clinical site management and clinical trial site monitoring functions

• Participating as a member on assigned cross functional study team

• Assisting with the design and review of clinical trial protocols, informed consent, case report forms (CRFs), Statistical Analysis Plan, and Clinical Study Report in collaboration with medical monitor, biostatistician, regulatory affairs, senior management and other relevant groups. Participating in the

Clinical Protocol Committee as appropriate.

• Creating and maintaining clinical trial start-up documents such as the Clinical Monitoring Plan. Developing or providing clinical operations / clinical trial monitoring function input for other clinical

trial start up activities, including; investigational drug supply plan, research specimen plan, CRF Completion Guidelines and other plans and processes as appropriate.

• Leading identification, evaluation and selection of clinical trial investigators/sites

• Managing clinical trial site monitoring team metrics (i.e. monitoring frequency and trip report

completion, CRFs expected/outstanding, Source Document Verification (SDV) progress, query

aging, monitoring resource requirements, etc.) to ensure performance maximizes efficiency, quality, ICH/GCP adherence, and meet clinical trial and corporate goals.

• Providing support to Field Clinical Research Associates (CRAs) and assisting in the initiating,

monitoring and coordinating day-to-day operations of clinical trial sites. Conducting monitoring visits

including pre-study, initiation, interim monitoring and close visits as needed.

• Coordinating and managing vendor processes for the clinical trial site monitoring function of clinical

trials including central laboratories and Clincial Research Organizations (CRO).

• Being the primary contact for CROs Clinical Trial Site Monitoring Team to ensure CRO’s performance

to the terms of contract, CFR, ICH/GCP compliance, and overall quality of work.

• Overseeing research specimen collection, including accountability, monitoring, reconciliation, and

shipment as needed.

• Facilitating information flow between clinical trial sites, clinical project team members and other members of the clinical operations team, external CRO or contracted members, clinical field team,

vendors, and other personnel as appropriate.

• Ensuring completeness of Clinical Trial Management System (CTMS) and Trial Master File (TMF)

for assigned studies.

• Assisting in the preparation and follow-up of in-house and on-site Client sponsored quality audits,

as well as, regulatory authority inspections.

Leading functional teams within the Clinical Trial Management department

• Ensuring assigned clinical study team adheres to clinical operations or project-specific quality

documents (e.g., SOPs, work practices, training guides).

• Completes training assigned by Client and/or EP, as necessary, including general training

requirements, SOPs, and system and process related training

• Adheres to EP and Client SOPs and processes

Management

• Clinical Trial Manager is responsible for managing other external clinical trial service vendors as

necessary.QualificationsSkills and Education:

▪ BA/BS or equivalent or any relevant and qualifying training with a minimum of 8 years of

relevant Pharmaceutical/Biotech Industry experience. An advanced degree is a plus ▪ Experience in Phase I-III trials and CRO management is preferred.

▪ Experience managing large teams (dotted line reporting) is preferred.

▪ Oncology clinical research experience preferred

▪ Ability and willingness to travel (domestic and internationally)

▪ Thorough knowledge of CFR and GCP/ICH requirements. Knowledge of European Clinical

Trial Directive is preferred..

▪ Excellent communication and organization skills.

▪ Exceptional ability to plan, organize and manage clinical trials

▪ Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, SharePoint) and other

electronic systems (CTMS, EDC and eTMF)

This role may be subject to government and/or customer requirements regarding vaccination against COVID-19 that are more stringent than Parexel policy. Accordingly, successful applicants may need to be either vaccinated against COVID-19 or have an approved religious or medical exemption. Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

#INFSPEEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.