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Full professional name
Primary institutional affiliation
Department/Unit
Professional e-mail
Preferred notification channel
Encrypted app (Signal/Element)
Institutional Slack/Teams
Other:
Select your primary technical domains (max 5)
Early-phase clinical pharmacology
Late-phase efficacy trials
Cell & gene therapy manufacturing
Bioprocess development & scale-up
Companion diagnostics
Bioinformatics & AI-driven analysis
Regulatory strategy & submissions
Quality systems & audits
Data integrity & CSV
Risk management & safety
Other:
Rate your proficiency in the following cross-functional skills
Novice | Advanced Beginner | Competent | Proficient | Expert | |
|---|---|---|---|---|---|
Protocol design & statistical planning | |||||
ICH-GCP compliance | |||||
GLP/GMP environment | |||||
ISO 14155 (device) standards | |||||
Risk-based monitoring | |||||
Digital health integration | |||||
Technology transfer | |||||
Regulatory writing | |||||
Audit & inspection readiness | |||||
Team leadership in matrix organizations |
Which best describes your primary workspace?
BSL-1 academic lab
BSL-2 clinical lab
BSL-3 containment facility
GMP biomanufacturing suite
GMP cell & gene therapy clean-room
Animal facility
In silico/dry lab
Remote/hybrid
Other
Do you have aseptic processing certification?
Date of most recent aseptic re-certification
Have you led technology-transfer activities (process scaling, analytical method transfer)?
Briefly describe the most complex transfer you managed and key lessons learned
Equipment you are qualified to operate independently
Single-use bioreactors (50 L–2000 L)
High-throughput perfusion systems
Flow cytometry (analyser & sorter)
qPCR/ddPCR platforms
LC-MS/MS for biologics
Next-gen sequencers
Automated ELISA systems
Closed-system cell processors
Other
List critical reagents or reference standards you have qualified or released
Reagent / Standard | Catalog / in-house ID | Expiry date | Storage condition | Stability study performed? | ||
|---|---|---|---|---|---|---|
A | B | C | D | E | ||
1 | ||||||
2 | ||||||
3 | ||||||
4 | ||||||
5 | ||||||
6 | ||||||
7 | ||||||
8 | ||||||
9 | ||||||
10 |
Highest regulatory scope you routinely support
Pre-clinical/CMC only
Phase I first-in-human
Phase II proof-of-concept
Phase III confirmatory
Post-marketing surveillance
Combination product
IVD companion diagnostic
Regulatory authorities you have interacted with (inspections, scientific advice, submissions)
EMA/EU-NCA
FDA/CDER/CBER
PMDA
NMPA
TGA
Health Canada
Swissmedic
WHO pre-qualification
Other
Have you ever managed a critical CAPA (Corrective & Preventive Action) tied to data integrity?
Describe root cause, impact assessment, and preventive measures implemented
Do you currently work under a validated Quality Management System (QMS)?
Explain how quality events are managed without a formal QMS
Rate your comfort level with the following data-integrity topics
Never heard | Heard only | Basic understanding | Comfortable | Expert | |
|---|---|---|---|---|---|
ALCOA+ principles (Attributable, Legible, Contemporaneous, etc.) | |||||
21 CFR Part 11 / EU Annex 11 compliance | |||||
Audit trail review frequency | |||||
Raw data archiving & retrieval | |||||
Risk-based validation of spreadsheets | |||||
Cloud-based clinical data platforms | |||||
Blockchain for immutable records |
Approximate number of protocols you have authored or co-authored
Approximate number of sites you have monitored or managed simultaneously
Preferred trial design philosophy
Traditional parallel RCT
Adaptive platform
Bayesian dose-finding
Real-world evidence hybrid
Decentralised/virtual
Other
Do you have experience with decentralized clinical trial (DCT) technologies?
Which DCT components have you deployed?
e-Consent
Wearables data capture
Home nursing
Direct-to-patient drug logistics
Tele-visits
AI-driven ePRO reminders
How would you rate patient-centricity in your past trials?
Not considered
Minimal
Moderate
High
Patient-partner driven
Provide up to 3 recent studies (≤ 5 years) you led or significantly contributed to
Study short name / identifier | Phase | Primary indication | Target no. | First patient first visit | Primary completion | Trial achieved primary endpoint? | ||
|---|---|---|---|---|---|---|---|---|
A | B | C | D | E | F | G | ||
1 | ||||||||
2 | ||||||||
3 |
Indicate modalities you have advanced beyond proof-of-concept
mRNA/sa-mRNA therapeutics
CRISPR/Cas in-vivo editing
Ex-vivo autologous CAR-T
Allogeneic CAR-NK
AAV-based gene therapy
Lentiviral engineered HSC
siRNA/antisense oligos
Microbiome live biotherapeutics
Personalized neo-antigen vaccines
Other
Have you managed CMC development for a product granted RMAT, ATMP PRIME, or SAKIGAKE designation?
Summarize regulatory incentives utilized and timeline impact
Rate your familiarity with Quality-by-Design (QbD) for biologics (1 = no exposure, 5 = authored QbD dossiers)
Have you implemented continuous manufacturing (perfusion or integrated) for biologics?
State product type, scale, and key PAT tools deployed
List analytical methods you have validated for advanced therapy characterization
Method | Mode (ELISA, qPCR, LC-MS...) | Matrix (cell lysate, serum, viral vector...) | Phase for which validated | CDER / EMA reviewed? | ||
|---|---|---|---|---|---|---|
A | B | C | D | E | ||
1 | ||||||
2 | ||||||
3 | ||||||
4 | ||||||
5 |
Have you chaired a Data Safety Monitoring Board (DSMB) or equivalent independent committee?
How many DSMB reviews have you chaired?
Your most advanced qualification in pharmacovigilance
None
Internal training only
CIOMS V/VI certified
DIA Pharmacovigilance certificate
Master's level coursework
Board certified (e.g., BCPS with safety focus)
Have you managed a Suspected Unexpected Serious Adverse Reaction (SUSAR) in a blinded trial?
Describe the un-blinding strategy and regulatory timeline
Rate your involvement with the following risk-assessment tools
Never used | Observer only | Contributor | Lead author | Global trainer | |
|---|---|---|---|---|---|
Failure Mode Effects Analysis (FMEA) | |||||
Fault Tree Analysis (FTA) | |||||
Hazard Operability Study (HAZOP) | |||||
Quality Risk Management per ICH Q9(R1) | |||||
Patient Risk Evaluation and Mitigation Strategies (REMS) |
Do you have formal crisis-communication training (media, social, regulatory)?
How would you handle a sudden safety signal that attracts public attention?
Which digital technologies are you currently deploying in trials or manufacturing?
AI-driven patient recruitment
Machine-learning process control
Digital twins for scale-up
Blockchain for temperature chain traceability
Real-time release testing via PAT
AR/VR for training
Synthetic control arms
Edge computing for remote sites
Other
Have you validated an AI algorithm under GxP?
Outline validation approach and regulator feedback
Rate your comfort with coding or scripting (1 = Excel formulas only, 5 = develop R/Python packages)
Do you have experience with FAIR (Findable, Accessible, Interoperable, Reusable) data principles?
What barriers prevent FAIR implementation in your projects?
List AI/ML projects you have led or significantly contributed to
Project name | Use case (e.g., predictive maintenance, image analysis) | GxP relevance | Model type (CNN, RF, XGBoost...) | Model validated? | ||
|---|---|---|---|---|---|---|
A | B | C | D | E | ||
1 | ||||||
2 | ||||||
3 | ||||||
4 | ||||||
5 |
Have you implemented green chemistry or sustainable manufacturing initiatives?
Describe metrics used (E-factor, LCA, carbon footprint) and outcome
How would you rate the maturity of ESG (Environmental, Social, Governance) reporting in your organization?
Not considered
Informal
Developing
Integrated
Leader
Select ethical frameworks you routinely apply
CIOMS guidelines
Declaration of Helsinki
Belmont Report principles
ICH E6(R3) draft
ISO 37000 (organizational governance)
Conformité Européenne (CE) mark ethics
Other
Have you worked with patient advocacy groups in trial design?
Explain how patient input changed the protocol
Do you support open-access publication of negative trial results?
What barriers limit open-access sharing?
Describe any community-benefit agreements or equitable-access clauses you have negotiated for low- and middle-income countries
List up to three scientific societies or consortia where you hold active leadership roles
Preferred collaboration model
Single-site academic
Multi-site academic consortium
Public–private partnership
Industry-sponsored
Joint venture biotech
Other
Are you interested in acting as a mentor (≤ 2 junior professionals/year)?
Specify areas you wish to mentor in
Would you be open to short-term global travel (≤ 15% of your time)?
Outline restrictions (visa, family, health) and acceptable remote contribution
Languages in which you can conduct scientific discussions
English
中文
Español
Français
Deutsch
Português
日本語
Русский
العربية
Other
Rank the following incentives by what most motivates you to join a new project (1 = highest)
Scientific novelty | |
Equity/stock options | |
Flexible schedule | |
Global impact potential | |
Collaborative team culture | |
Rapid decision-making | |
Other |
Provide a brief vision statement describing the impact you want your work to have in the next decade
Please upload documents in PDF, PNG, or JPEG format. Redact personal identifiers if required by your institution.
Current CV/résumé (max 10 MB)
GCP/GMP/GLP certificates (merge into single file, max 10 MB)
Professional headshot (optional, for internal directory only)
Do you consent to share your anonymized profile data for aggregate workforce analytics?
Thank you. Your data will help identify global gaps in clinical research capacity.
Your decision will not affect your eligibility for future opportunities.
I confirm that the information provided is accurate to the best of my knowledge
Signature
Analysis for Clinical Research & Biotechnological Development Professional Profile
Important Note: This analysis provides strategic insights to help you get the most from your form's submission data for powerful follow-up actions and better outcomes. Please remove this content before publishing the form to the public.
This form excels at capturing the multi-dimensional expertise required for clinical research and biotechnological development professionals. The structure follows a logical progression from basic identity through highly specialized technical competencies, regulatory knowledge, and forward-looking digital skills. The comprehensive nature ensures that organizations can make informed decisions about candidate placement while maintaining strict data integrity standards required in regulated environments.
The form's sophisticated branching logic and conditional follow-ups demonstrate deep understanding of the field's complexity. Rather than using generic questions, each section targets specific competencies like GMP environment experience, data integrity principles, and advanced therapy modalities. This granular approach enables precise matching between professionals and projects while reducing mismatches that could compromise research outcomes or regulatory compliance.
Full professional name (Mandatory)
This mandatory field serves as the primary identifier for credential verification, publication matching, and regulatory documentation. The form correctly prioritizes this as required information since accurate professional identification is fundamental for compliance with regulatory requirements and maintaining audit trails in clinical research environments.
Primary institutional affiliation (Mandatory)
By making this mandatory, the form ensures institutional credibility verification and enables proper conflict-of-interest screening. This information is crucial for multi-site studies where institutional reputation and capabilities directly impact study feasibility and regulatory approval processes.
Professional e-mail (Mandatory)
The mandatory email requirement enables secure communication channels for sensitive research information while providing a verifiable contact method for regulatory correspondence. This field's mandatory status reflects the digital nature of modern clinical trials where email serves as the primary documentation and notification system.
Select your primary technical domains (max 5)
The limitation to five choices forces professionals to prioritize their strongest competencies, creating clearer profiles for project matching. The comprehensive option list covers the full spectrum from early-phase pharmacology to AI-driven analysis, reflecting the field's evolution toward digital integration while maintaining traditional core competencies.
Rate your proficiency matrix
The matrix format efficiently captures nuanced skill levels across ten critical competencies in a single interaction. The progressive scale from "Novice" to "Expert" provides clear differentiation while the inclusion of "Advanced Beginner" acknowledges the learning curve typical in complex regulatory environments.
Primary workspace description
This single-choice question efficiently categorizes professionals into operational environments that directly impact their available skillsets and project suitability. The options progress logically from basic BSL-1 through specialized GMP facilities, enabling quick filtering for facility-specific requirements while acknowledging modern remote work possibilities.
Aseptic processing certification
The yes/no branching with date follow-up cleverly captures both current qualification status and recency, critical for GMP compliance where certifications expire. This design prevents data decay by ensuring time-sensitive qualifications remain current and traceable.
Highest regulatory scope
This question's progression from pre-clinical through post-marketing surveillance accurately reflects the regulatory journey, enabling precise matching for projects at specific development stages. The inclusion of combination products and companion diagnostics acknowledges the field's increasing complexity.
Data integrity comfort matrix
The seven-item matrix covering ALCOA+ principles through blockchain integration demonstrates forward-thinking design that captures both current compliance requirements and emerging technologies. This comprehensive approach ensures professionals can be matched with organizations at varying levels of digital transformation.
Protocol authorship count
The numeric input for protocol authorship provides quantitative evidence of experience level while the approximate nature acknowledges that exact counts may not be readily available. This metric directly correlates with leadership capability and regulatory writing competence.
Decentralized trial technologies
The branching yes/no question efficiently captures DCT experience while the follow-up multiple-choice identifies specific technology familiarity. This design acknowledges that DCT implementation varies widely and enables precise matching for hybrid trial designs.
Modalities beyond proof-of-concept
The extensive option list covering mRNA, CRISPR, CAR-T, and microbiome therapies reflects cutting-edge bioprocessing requirements. By focusing on "beyond proof-of-concept," the form filters for professionals with commercialization experience rather than purely research backgrounds.
Quality-by-Design familiarity
The 1-5 digit rating provides granular assessment of QbD expertise, crucial for regulatory submissions. The scale descriptions clearly differentiate between no exposure and dossier authorship, enabling precise capability assessment.
DSMB chairing experience
The yes/no branching with numeric follow-up for chair counts efficiently captures leadership experience in critical safety oversight. This metric directly indicates seniority level and regulatory responsibility capacity.
SUSAR management in blinded trials
This specialized question targets expertise in maintaining trial integrity during serious adverse events, a critical competency for Phase III studies. The follow-up text field enables assessment of strategic thinking and regulatory knowledge.
AI algorithm validation under GxP
This forward-looking question identifies professionals capable of implementing AI in regulated environments, a rapidly growing requirement. The follow-up text field captures regulatory feedback, indicating real-world implementation experience versus theoretical knowledge.
FAIR data principles experience
The yes/no branching acknowledges that FAIR implementation remains emerging practice while the "no" follow-up identifies implementation barriers, providing valuable market intelligence on adoption challenges.
Green chemistry initiatives
This question positions environmental responsibility within the traditionally resource-intensive biopharma sector. The follow-up requesting specific metrics enables verification of claimed initiatives while identifying measurable sustainability practices.
Patient advocacy group collaboration
The yes/no question with protocol impact follow-up demonstrates patient-centric trial design, increasingly required by regulators. This field identifies professionals who can navigate the complex intersection of scientific rigor and patient needs.
Leadership in scientific societies
The open-ended format with three-item limitation efficiently captures professional network breadth while preventing excessive listing. Leadership roles in respected societies serve as peer validation of expertise.
Vision statement
The 150-word limit forces concise articulation of professional goals while providing insight into candidate motivation and alignment with organizational missions. This qualitative field adds human context to technical qualifications.
The form's comprehensiveness, while a strength, may discourage completion by busy professionals. The estimated completion time exceeds 45 minutes, potentially limiting responses to only the most motivated candidates. Consider implementing a save-and-return feature or breaking into multiple sessions.
Several technical sections assume familiarity with specific equipment or methodologies that may not translate across all geographic regions or institutional contexts. Adding "equivalent experience" options could improve international applicability while maintaining data quality.
Mandatory Question Analysis for Clinical Research & Biotechnological Development Professional Profile
Important Note: This analysis provides strategic insights to help you get the most from your form's submission data for powerful follow-up actions and better outcomes. Please remove this content before publishing the form to the public.
Full professional name
This field must remain mandatory as it serves as the primary identifier for credential verification, publication database matching, and regulatory documentation. In clinical research, accurate professional identification is fundamental for maintaining audit trails, ensuring compliance with Good Clinical Practice guidelines, and enabling proper attribution of research contributions. Without verified names, institutions cannot perform essential background checks or maintain proper investigator qualifications files required by regulatory authorities.
Primary institutional affiliation
Mandatory institutional affiliation enables critical conflict-of-interest screening and verifies the professional's access to necessary research infrastructure. This information directly impacts study feasibility assessments since institutional reputation and capabilities influence regulatory approval processes and sponsor confidence. The affiliation also determines available resources, IRB access, and institutional review capabilities that are essential for multi-site clinical trials.
Professional e-mail
Email addresses must remain mandatory as they serve as the primary communication channel for sensitive research information, regulatory notifications, and project coordination. In modern clinical trials, email systems often integrate with clinical trial management systems for automated alerts, protocol amendments, and safety reporting. Without verified email addresses, professionals cannot receive critical time-sensitive information that could impact patient safety or regulatory compliance.
I confirm that the information provided is accurate
This mandatory checkbox creates legal attestation essential for regulatory compliance and liability protection. In clinical research, accuracy of professional credentials directly impacts patient safety, data integrity, and regulatory standing. The attestation serves as a quality control measure, ensuring professionals take responsibility for their representations while providing legal recourse for organizations relying on the provided information for critical research decisions.
The current mandatory field strategy demonstrates excellent restraint by requiring only four essential fields, representing less than 5% of total questions. This minimal approach maximizes form completion rates while ensuring critical identification and verification data collection. The strategy correctly prioritizes fields that enable basic professional verification without creating barriers that might discourage qualified candidates from completing the comprehensive assessment.
Consider implementing conditional mandatory fields based on user responses to enhance data quality without increasing abandonment rates. For instance, if professionals indicate GMP experience, mandatory follow-ups for certification dates could ensure current qualifications. Similarly, regulatory submission experience could trigger mandatory fields for specific agency interactions. This dynamic approach would maintain completion rates while ensuring relevant professionals provide complete qualification data essential for project matching accuracy.
To configure an element, select it on the form.