This role is responsible for comprehensive trial an********administration. Under the oversight of the Senior COM or COMs, theperson prepares, collates, distributes an******** clinical documents.
The CTC supports clinical supply & non-clinical supply managementan******** timely maintenance of tracking an******** tools, asapplicable.
The role is critical to meet planne******** Ready ******** includingassisting with the preparation of submission packages to IRB/ERCan******** Authorities. The role will collaborate at local level closelywith COM, CRM an********. An******** person collaborates withfinance/budgeting representatives to manage CTRAs an********.
Responsibilities ******** but are not limite********:
1. Document managemen********
- Prepare documents an********
- Collate, distribute/sh******** an******** clinical ******** e.g. eTMF
- Assist with eTMF reconciliation
- Execute eTMF Quality Control Plan
- Document proper destruction of clinical supplies.
- Obtain translations of documents
2. Regulatory & Site Start-Up responsibilitie********
Collaborate with other country roles to:
- In a timely manner, provide to an******** from investigatorsform******** for site evaluation/val******** site start-up an********
- Obta******** track an******** study insurance certificates
3. Bu******** Agreement an****************
Collaborate with finance/budgeting representatives for:
- Develop, control, update an********-out country an******** budgets(including Split site budget)
- Develop, negot******** approve an******** contracts (e.g. CTRAs)
- Track an******** contract negotiations
- Update an******** contract templates (in cooperation with LegalDepartment)
- Calculate an******** payments (to ******** ven******** grants)
- Ensure adherence to financial an******** procedures
- Monitor an******** adherence an********,
- Maintain tracking tools
- An******** of financial systems.
CORE Competency Expectation********
- Fluent in Local Languages an******** proficient in English (verbalan********) an******** communication skills
- Goo******** of Global, Country/Regional Clinical Research Guidelinesan******** to work within these guidelines.
- Hands on knowledge of Goo******** Practices
- Goo******** skills (Use of MS off******** use of some clinical ITapplications on computer) an******** to adapt to new IT applications.Strong MS Excel skills required.
- ICH-GCP Knowledge appropriate to role
- Excellent negotiation skills for CTCs in finance area
Behavioral Competency Expectation********
- Effective time management, organizational an******** sk********conflict management
- Effective communication with external customers (e.g. Sitesan********)
- High sense of accountability / urgency. Ability to set prioritiesan******** multiple tasks simultaneously in a changing environment
- Works effectively in a matrix multicultural environment. Ability toestablish an******** culturally sensitive working relationships.
- Demonstrates commitment to Customer focus, both internally an********.
- Able to work independently
- Proactive attitude to solving problems / proposing solutions
Experience Requiremen********
- Minimum 1 year working experience.
- Experience as CRC/CTC/SSU in CRO/Pharma is preferred.
- BD Suppor******** Marketing Speciali******** Sales Support inCRO/Pharma will be considere******** well.
Educational Requiremen********
-Bachelor's Degree (or comparable) in Business Finance/Administration/Life Science/ Pharmaceutical/ Nursing or equivalent Health Care relate********.