This is a full-time employment opportunity for a clinical trial manager (ctm) in the san francisco area.
-responsible for coordinating and monitoring the day-to-day logistics of our clinical trials.
-manage clinical trial operations including vendor performance, internal/external metrics, and communication of project status within the project team
-manage and track completion of study start-up, conduct, and closeout activities to industry and corporate standards
-ensure the progress and completion of projects according to timelines
-prepare and present project specific updates
-lead or assist in the writing of clinical documents such as protocols, study reports, study manuals, and annual reports
-monitor safety surveillance and reporting activities
-oversee data management processes including collection and cleaning of clinical database, reconciliation of clinical and safety databases, and data interpretation and evaluation
-coordinate dsmb/safety reviews inline with charter and overall study parameters
-assist in the construction of clinical development processes including development and writing of sops, creation and organization of study trial master files, and clarification of organization and workflow structures
-plan, generate, and track study timelines and trial budgets
-site management activities including: review monitoring reports, interact with study monitors, track site errors or other indicators of site difficulties, identification of potential problem sites and development of corrective action plans as required, acting as our contact, as needed, for clinical sites
-ba/bs degree in biological science or nursing required (equivalent experience may be accepted)
-5+ years of clinical research in the biotechnology/pharmaceutical industry
-3+ years of multi-center clinical trial management experience, specifically experience in phase 2, phase 3 us & international clinical trials
-experience managing cros, central laboratories, and other clinical study vendors
-experience preparing clinical trial budgets and contracts
-knowledge of ich-gcps and 21 cfr is required
-experience in metabolic/hepatic drug development is desirable
-experience with ivrs and/or edc is desirable+24 Other Responses
Saas For Clinical Trials - Srm Research
We are a global market research firm and are seeking experts who can assist us with information about ‘medidata solutions’ as a candidate for preferred supplier in the eclinical solutions space
please elaborate on following questions for “medidata solutions” as one of the suppliers:
1. How competitive is medidata solutions as compared to other vendors in terms of quality, cost and innovation?
2. Comment on supplier readiness on different areas of opportunities – e.G. Cost reduction, innovation, risk mitigation etc.
3. Mention a few srm initiatives between medidata solutions and top biotechnology or pharmaceutical companies.
4. Mention major clients and their present spend with medidata solutions?
5. How does medidata solutions rank as a eclinical solutions provider when compared to similar companies in this space?
6. What are the key negotiation levers at supplier and industry level?
7. How does medidata solutions plan to manage competition in future?
8. List of top 10-20 accounts (clients) in the eclinical solutions space that medidata solutions is a supplier for. Top 5 cash cows for medidata solutions and estimated account sizes ($ value).
Ideal candidates should have deep knowledge of medidata solutions and its capabilities, financials and client structure
we are looking for a phone consult for a time of 1 hour to discuss all points mentioned above.
Kindly drop in a note with your cv/relevant experience in the decentralized clinical trial market, if you are interested to proceed.+undefined Other Responses
Clinical Trial Investigators
We are looking for an expert who can help us do a clinical trial investigator fees / role benchmarking.
1) standardize how high range benchmarks are calculated for investigator fees; e.G. What percentile (50th, 75th, 80th, 90th, 100th ) is used by each segment of the industry to set the upper limit for investigator fees benchmarks
2) is inflation included in the calculations? Is this assessed every year or projected at the time of the contract.
3) how are companies organized around the generation of fmv (per segment/ per region where applicable)? Centrally managed by internal team? Part of operations or stand alone
4) to what level is fmv assessed? Line item, visit, patient; how is overhead assessed is there a company maximum? What is the governance for companies that are above the upper limit of the benchmark for fmv
5) how are the negotiations managed with the investigators? Centrally by internal team, decentralized through regional functions, cro only, specific service provided by specialty vendor, online tool?
6) what is tco for other companies per segment?
7) how are the contractual obligations managed? (automatic feed to electronic data, investigator tracking on central database?)
8) what are the triggers for payment release of investigator fees? Is it recruitment, visit completion, availability of data/clean data?
9) is the processing of invoices from investigators managed centrally (specialist team receiving information from all investigators worldwide?)
10) how are investigators paid?+undefined Other Responses