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Sr. / Clinical Trial Specialist (Clinical)

Company: ProPharma Group
Location: Durham
Posted on: January 26, 2023

Job Description:

Company Description

ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group's fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today's dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes.

Job Description

Essential Duties and Responsibilities:

--- Work with the Clinical Trial Managers, and other study team members, to educate and train study sites, or study teams, as needed.

--- Work with study sites to obtain required regulatory documentation during most phases of the study.

--- May prepare, manage and track study-specific contracts, budgets, and clinical study payments in applicable systems.

--- Completes loading and QC of TMF documents to the appropriate system, or central mailbox, as needed to support the department.

--- Provides document management support to clinical teams for study maintenance and other periods of high volume document flow as assigned.

--- Manage and track clinical and non-clinical supplies.

--- Track and prepares study information utilizing databases, spreadsheets, and other tools (i.e. SharePoint, SmartSheet, etc).

--- Manage and distribute study-related materials to all study sites as requested.

--- Ability to work cross-functionally with multiple departments.

--- Enter all new study site or ongoing information into eTMF and any other applicable Clinical Trial Operations system, as applicable.

--- Participates in TMF SOP reviews and ensures TMF QC process is managed across all trials.

--- Collaborate on and continuously look for opportunities to streamline and improve processes.

--- Assist in training or mentoring new employees on the CTS activities or other CTS study-related processes.

--- Other study-related administrative duties as needed.

--- Adhere to all required Standard Operating Procedures (SOP's)

Qualifications

Qualified candidates must have:

--- A minimum of 4 years experience working with clinical trials.

--- Worked across at least two phases of studies.

--- 2 years eTMF uploading and QC experienced required.

--- Strong written and verbal skills.

--- Ability to work as part of a team comprised of internal employees, contractors and managers.

--- Ability to multitask and take on various projects.

--- Must be able to prioritize and manage a large volume of work and show attention to detail.

--- Ability to work with self-discipline, good judgment and independence in a dynamic office or remote setting.

--- Excellent written, verbal communication skills are required, as is computer proficiency.

--- Excellent keyboard skills, with experience using Microsoft Office (Word, Excel, PowerPoint) applications to prepare charts, tables, forms, reports, and presentations.

--- Experience with e-mail and calendar programs. Flexibility with respect to working hours based on operational need.

Qualifications

Qualified candidates must have:

--- A minimum of 4 years experience working with clinical trials.

--- Worked across at least two phases of studies.

--- 2 years eTMF uploading and QC experienced required.

--- Strong written and verbal skills.

--- Ability to work as part of a team comprised of internal employees, contractors and managers.

--- Ability to multitask and take on various projects.

--- Must be able to prioritize and manage a large volume of work and show attention to detail.

--- Ability to work with self-discipline, good judgment and independence in a dynamic office or remote setting.

--- Excellent written, verbal communication skills are required, as is computer proficiency.

--- Excellent keyboard skills, with experience using Microsoft Office (Word, Excel, PowerPoint) applications to prepare charts, tables, forms, reports, and presentations.

--- Experience with e-mail and calendar programs. Flexibility with respect to working hours based on operational need.

Additional Information

  • All candidates must be legally eligible to work in the United States.
  • ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Keywords: ProPharma Group, Durham , Sr. / Clinical Trial Specialist (Clinical), Healthcare , Durham, North Carolina

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