Planet Pharma
Job Description
Job Profile: Minimum BS/BA degree with 2+ years clinical experience. Site/CRO/Sponsor experience. Similar roles are - Sr CTAs. No need to submit any CRAs as they will not be considered with this team. Most successful temp hires have more than the minimum yeas experience. Good communication skills is a must.
Organizes and delivers analyzable reports and metrics to the clinical study lead Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings Collates data for assessments such as feasibility and site selection and reviews site usability database Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders Collates materials for training and investigator meetings Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance Ensures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form) Manages and maintains team SharePoint and/or shared drive sites, as needed Communication with sites as directed and maintains site contact information Contributes to line listings review for Blind Data Review Meeting (BDRM) May manage or contribute to oversight of Third Party Vendors (TPV) Tracks and monitors close out activities - study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives Proactively recommends process improvement initiatives for the department May require up to 25% travel
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Job Profile: Minimum BS/BA degree with 2+ years clinical experience. Site/CRO/Sponsor experience. Similar roles are - Sr CTAs. No need to submit any CRAs as they will not be considered with this team. Most successful temp hires have more than the minimum yeas experience. Good communication skills is a must.
Organizes and delivers analyzable reports and metrics to the clinical study lead Schedules and coordinates meetings, prepares agendas, presentation materials and minutes for clinical study team meetings and other study related meetings Collates data for assessments such as feasibility and site selection and reviews site usability database Contributes to review of study documents such as informed consent forms, case report forms and facilitates study document reviews per company standard operating procedures Compiles study manuals including but not limited to: study reference binders and manuals and maintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders Collates materials for training and investigator meetings Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan Monitors and updates investigator/site status for the trial, and supports with clinical trial registry postings Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study lead guidance Ensures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form) Manages and maintains team SharePoint and/or shared drive sites, as needed Communication with sites as directed and maintains site contact information Contributes to line listings review for Blind Data Review Meeting (BDRM) May manage or contribute to oversight of Third Party Vendors (TPV) Tracks and monitors close out activities - study close-out documents (1572s, Investigational Product reconciliation, Financial Disclosures, etc.) and CRA close-out visits Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives Proactively recommends process improvement initiatives for the department May require up to 25% travel
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.