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ExecuPharm FSP- Senior Clinical Trials Manager

Parexel International Corporation

USA - Any Region - Home Based

ExecuPharm FSP Clinical Trial Manager (CTM)

The CTM position has two primary responsibilities: Execution of clinical trial including site monitoring functions of a clinical trial, and management of staff (indirect) within the clinical study team.

· Reports to ExecuPharm Line Manager with day-to-day direction from the Client.

· Liaises with cross functional lines as appropriate.

· 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, 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 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 CROs.

· 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 CTMS and 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

· 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)EEO 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.

Job posted: 2021-01-28