Are you a biotech or pharma company looking for clinical operations and biometrics staff to work on your clinical trial?
Sofpromed provides flexible, quick, and hourly-based staffing solutions for biotech and pharma companies conducting phase I-IV clinical trials worldwide.
We offer highly-qualified clinical operations and biometrics professionals with flexible dedication and on a contract basis fully adapted to your specific needs.
Whether you are seeking to strengthen your statistical programming team for some months or you are looking for a clinical study coordinator to work on your clinical trial on a long-term contract, we can provide the right person for you.
More specifically, we can facilitate the following clinical trial personnel to be integrated in your team:
- Clinical Project Managers
- Clinical Trial Managers
- Clinical Research Associates (CRAs)
- Clinical Data Managers
- Study Coordinators (working at the clinical site’s facilities)
- Medical Monitors
- Statistical Programmers
Our staffing solutions are available in all major clinical research regions around the world and in the following therapeutic areas (among others):
- Central nervous system
- Infectious diseases
What are the advantages of Sofpromed’s clinical research personnel recruitment solutions?
Sofpromed’s clinical research staff recruitment solutions are based on a Functional Service Provider (FSP) approach.
In a FSP model, a clinical research organization (CRO) provides clinical trial personnel (e.g. Clinical Project Managers or Statistical Programmers) to a biotech or pharma company, to work on specific tasks on a contract basis, instead of providing a full service for the whole clinical trial or development program.
One of the main advantages of the FSP model is the possibility of hiring qualified staff quickly by saving recruitment costs and internal human resource management overheads.
Clinical trial sponsors can hire specific profiles with great flexibility during defined time intervals (e.g. peak workload periods) on an on-demand basis, avoiding traditional employee contracting costs.
Another clear major benefit of this model for sponsors is that it provides access to best-in-class highly specialized professionals by specific functions.
FSP agreements have traditionally included functions such as clinical data management, biostatistics, and statistical programming.
However, other services such as project management, site management, clinical monitoring, and medical monitoring have been increasingly offered under FSP contracts as well.
FSP relationships continue to play a key role in the clinical research industry.
Many of the top pharma companies include FSPs as a significant component in their long-term outsourcing strategies.
How does an FSP contract work?
Firstly, you can send us an email to email@example.com, or use our contact form, to let us know about the type of clinical or biometrics profile you need to add to your team, along with the estimated duration of the expected contract.
Secondly, we will get in touch with you and send you the CVs of potential candidates meeting your requirements. These candidates will be available for an interview with you.
Finally, if all goes well, a contract will be discussed and signed to formalize the agreement.
What kind of clinical trial personnel do we offer?
Sofpromed offers the following specialists for biotech and pharma companies conducting phase I-IV clinical trials around the globe (we provide a description of their typical responsibilities):
Clinical Project Manager
- Oversees clinical trial activities
- Leads clinical operations teams
- Ensures effective and timely planning, implementation, coordination and reporting of the clinical study
- Plans and communicates study milestones, deliverables, timelines and quality standards
- Monitors vendor activities, including IMP management, Investigator contract/budgets, TMF management, and study set-up
- Identifies study-related issues and implements corrective actions
- Develops recruitment strategies
- Prepares study plans
- Contributes to the review of regulatory study documents
- Coordinates contract and budget negotiations with sites and third-party vendors
- Leads study operational feasibility and site set-up activities
- Prepares study training materials
- Reviews monitoring reports
Clinical Trial Manager
- Oversees and manages the clinical trial in accordance with SOPs and ICH/GCP
- Supervises study timelines and milestones
- Ensures compliance with key study quality metrics
- Oversees study start-up, enrollment, study conduct and close-out activities
- Identifies risks to study and develops risk mitigation plans
- Reviews monitoring reports and site performance
- Contributes to preparation of clinical protocols, amendments, informed consent forms, study manuals, and study plans
- Performs reviews of data listings and summary tables
- Organizes internal team meetings and investigator meetings
- Assists in the identification and evaluation of third party vendors
- Oversees performance of third party vendors
- Identifies areas of concern and escalates issues to upper management
- Manages invoices and financial aspects
- Monitors performance of investigational sites
- Manages IMP accountability and reconciliation processes
- Mentors other team members
- Reports on study progress
Clinical Research Associate (CRA)
- Conducts onsite visits (qualification, initiation, monitoring, and close-out visits)
- Obtains and reviews essential documents from clinical sites
- Maintains study documentation (eTMF, correspondence, visits reports)
- Ensures that the investigator and site staff are adequately trained on study procedures
- Ensures Serious Adverse Events (SAEs) are reported by sites
- Reports on the progress of the trial at sites
- Performs source data verification (SDV)
- Manages queries with sites through eCRF reviews
- Reviews data tables and listings
- Keeps communication with investigators concerning recruitment
- Identifies site issues escalating them to the project manager and/or sponsor
Clinical Data Manager
- Creates, maintains, and implements the Data Management Plan
- Develops case report form specifications
- Contributes to the annotated CRF
- Trains project teams on the case report form
- Interacts with clinical project managers, biostatisticians, and sponsor to develop specifications for the clinical database
- Builds the electronic data capture (EDC) system application
- Trains data entry staff on study specific data entry guidelines
- Develops specifications for edit checks
- Creates test cases and ensures edit checks are adequately programmed and tested
- Manages the user acceptance testing (UAT) process
- Reviews data listings and data validation reports for data discrepancies
- Manages data queries to resolve all data discrepancies
- Provides data status reports and data listings
- Develops specifications for transfer of electronic data from non-CRF sources
Study Coordinator (working at the clinical site’s facilities)
- Assists the Principal Investigator (PI) in the execution of the clinical trial
- Coordinates and facilitates monitoring visits, audits, and inspections
- Attends investigator meetings
- Maintains study files, including regulatory binders, and study specific source documentation
- Works with the PI to assure that the study is in compliance with the protocol, IRB approval, and GCP guidelines
- Under PI supervision, enrolls the patient into the clinical trial and communicates treatment assignment to clinical team
- Controls patient visits
- Ensures submission of radiology, pathology and cardiology tests and reports
- Manages clinical supplies
- Ensures biological samples are collected and shipped in a timely manner
- Ensures clinical and laboratory tests are adequately performed
- Reports all serious adverse events to study sponsor/CRO
- Performs data entry into the EDC system
- Resolves data queries
- Coordinates audits with study sponsors, FDA or other governing body and provides action plans or resolution to any audit finding
- Provides medical expertise for answering questions and resolving study-related issues
- Performs Adverse Event reviews and assists with drug safety questions
- Answers specific inclusion/exclusion criteria questions
- Responds to safety questions from the site or local IRB/IEC
- Evaluates causality on SAEs
- Provides the study team with medical advice for all medical issues during risk assessment and mitigation planning
- Performs reviews of individual subject safety data and cumulative safety data
- Monitors study safety issues and provides input to serious adverse events (SAEs) reports
- Responds to safety questions of the Data and Safety Monitoring Board (DSMB)
- Contributes to medical review and interpretation of efficacy and safety data
- Interacts with DSMBs and steering committees
- Provides statistical feedback into the protocol (e.g., trial design, sample size, randomization, statistical methods)
- Writes statistical analysis plans (SAPs)
- Validates statistical outputs
- Interprets statistical results
- Contributes to reports of clinical trial data
- Produces the statistical sections of the final report
- Provides inputs into statistical standard operating procedures (SOPs)
- Translates the SAP into programming specifications for analysis data model (ADaM) datasets
- Creates and reviews annotated CRFs
- Contributes to the development of case report forms, data management plans, statistical analysis plans, and TFL specifications
- Develops and validates SAS programs to generate standard (SDTM and ADaM) datasets
- Develops and validates SAS programs to generate Tables, Figures, and Listings
- Integrates databases from multiple sources
Please contact us to discuss your specific clinical trial staff needs.
For more information about clinical trial staffing solutions please contact us at firstname.lastname@example.org