Clinical Trial Manager-Tech Savvy-3989

ExecuPharm/Parexel FSP is looking for a Clinical Trial Manager (TECH SAVY) to work on assignment for Mitsubishi Tanabe.

100% remote US

ongoing assignment, no end date

ExecuPharm / Parexel FSP Offers full benefits, 401k, and paid time off (holidays, personal time, and sick time and an annual retention bonus).

Position Purpose:

The Clinical Trial Manager (CTM) will manage all operational aspects for implementation of one or more clinical trials and all activities from study start-up through database lock, ensuring Good Clinical Practices (GCP) and relevant SOPs are met. The incumbent will manage study-related service providers and serve as the primary point of contact for contracted CROs, study staff and contract labs as appropriate; identifying potential risks and resolving issues with CROs; and ensuring study feasibility is performed as appropriate.

Wearable device/mobile technology experience preferred; Vendor management strong required

Primary Duties:

Participates in CRO selection process, validate clinical scope of work, supports auxiliary service outsourcing provides input into vendor management plan, reviews quality metrics and shares lessons learned as required

Manages and executes vendor kick off meetings, face-to-face meetings, team training, and trial WebEx as required for trial execution.

Tracks and obtains necessary approvals related to vendor contract change orders.

Provides operational review and content to the study protocol and coordinates completion of QC review of the protocol.

Leads and/or supports clinical operational team meetings in support of the respective clinical trial

Provides input into and/or develops study related materials such as Clinical Monitoring Plans, Data Management Plans, eCRF forms and completion guidelines, protocols, patient informed consent drafts, site instructions for specimen collections, and approval for site receipt of study drug.

Performs and/or coordinates designees in processes related to designees’ monitoring report review, protocol deviations and data listings for sponsored studies to ensure reliable quality data are delivered.

Coordinates the CROs on site selection, IRB submissions, site initiation and close-out planning.

Tracks patient recruitment and progress to study timelines; supports site receipt of safety reporting; maintains and reports metrics for clinical study and CRO delivery performance.

Conducts and/or oversees site monitoring visits for clinical trials as needed

Provides oversight to staff maintaining clinical trial master files to ensure their compliance with required regulatory and GCP quality standards and consistency with company SOPs.

Provides input and support for trial site maintenance of appropriate documentation for adverse event safety monitoring.

Skills and Education:

Bachelor’s degree in health or biologic science (BS/BA/BScN); masters-level degree is preferred.

Minimum of 5 years of clinical study management experience in the biopharmaceutical industry, including a minimum of 2 years as a clinical study lead/project manager; global clinical trial experience is highly preferred.

Experience in management of contracted resources/CROs, site monitoring and clinical quality compliance

Strong CRO oversight and operational management skills with proven attention to detail required

Advanced knowledge of Good Clinical Practices and current knowledge of FDA regulations for IND clinical trials; international clinical trial experience and knowledge of other country regulatory requirements is preferred.

Effective oral/written communication and interpersonal skills

Advanced computer skills including proficiency in MS Office

Willingness to travel as required for key company meetings

Demonstrated ability to communicate and coordinate with internal and external team members

Able to proactively identify project challenges/risks and outline appropriate actions to Clinical Operations Team Lead, (COT-L)

#INFSPQualificationsExecuPharm/Parexel FSP is looking for a Clinical Trial Manager (TECH SAVY) to work on assignment for Mitsubishi Tanabe.

100% remote US

ongoing assignment, no end date

ExecuPharm / Parexel FSP Offers full benefits, 401k, and paid time off (holidays, personal time, and sick time and an annual retention bonus).

Position Purpose:

The Clinical Trial Manager (CTM) will manage all operational aspects for implementation of one or more clinical trials and all activities from study start-up through database lock, ensuring Good Clinical Practices (GCP) and relevant SOPs are met. The incumbent will manage study-related service providers and serve as the primary point of contact for contracted CROs, study staff and contract labs as appropriate; identifying potential risks and resolving issues with CROs; and ensuring study feasibility is performed as appropriate.

Wearable device/mobile technology experience preferred; Vendor management strong required

Primary Duties:

Participates in CRO selection process, validate clinical scope of work, supports auxiliary service outsourcing provides input into vendor management plan, reviews quality metrics and shares lessons learned as required

Manages and executes vendor kick off meetings, face-to-face meetings, team training, and trial WebEx as required for trial execution.

Tracks and obtains necessary approvals related to vendor contract change orders.

Provides operational review and content to the study protocol and coordinates completion of QC review of the protocol.

Leads and/or supports clinical operational team meetings in support of the respective clinical trial

Provides input into and/or develops study related materials such as Clinical Monitoring Plans, Data Management Plans, eCRF forms and completion guidelines, protocols, patient informed consent drafts, site instructions for specimen collections, and approval for site receipt of study drug.

Performs and/or coordinates designees in processes related to designees’ monitoring report review, protocol deviations and data listings for sponsored studies to ensure reliable quality data are delivered.

Coordinates the CROs on site selection, IRB submissions, site initiation and close-out planning.

Tracks patient recruitment and progress to study timelines; supports site receipt of safety reporting; maintains and reports metrics for clinical study and CRO delivery performance.

Conducts and/or oversees site monitoring visits for clinical trials as needed

Provides oversight to staff maintaining clinical trial master files to ensure their compliance with required regulatory and GCP quality standards and consistency with company SOPs.

Provides input and support for trial site maintenance of appropriate documentation for adverse event safety monitoring.

Skills and Education:

Bachelor’s degree in health or biologic science (BS/BA/BScN); masters-level degree is preferred.

Minimum of 5 years of clinical study management experience in the biopharmaceutical industry, including a minimum of 2 years as a clinical study lead/project manager; global clinical trial experience is highly preferred.

Experience in management of contracted resources/CROs, site monitoring and clinical quality compliance

Strong CRO oversight and operational management skills with proven attention to detail required

Advanced knowledge of Good Clinical Practices and current knowledge of FDA regulations for IND clinical trials; international clinical trial experience and knowledge of other country regulatory requirements is preferred.

Effective oral/written communication and interpersonal skills

Advanced computer skills including proficiency in MS Office

Willingness to travel as required for key company meetings

Demonstrated ability to communicate and coordinate with internal and external team members

Able to proactively identify project challenges/risks and outline appropriate actions to Clinical Operations Team Lead, (COT-L)

#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.