Study Start Up Manager

hace 6 meses

Buenos Aires, Argentina Bristol Myers Squibb A tiempo completo

**Working with Us**
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

Purpose/Objective of the job
- Responsible for activities related to study start up and ongoing study document management
- Act as point of contact for local study teams and external stakeholders

Key Responsibilities and Major Duties
- Independently manages multiple country, study and site level deliverables during start-up and maintenance both within BMS and external business partners and vendors, when required.
- Plans and develops strategy for start-up activities to ensure successful recruitment and delivery to trial milestones
- Prepare Investigator Sites to conduct clinical trials through the review and approval of essential clinical trial and regulatory documents
- Support local regulatory in preparing and performing submissions for Health Authorities including follow up until approval. This includes substantial amendments and any other documentation requiring HA submission.
- Prepare and perform submissions for Ethics Committees including follow up until approval (protocol, amendments/IB and any other documents requiring EC submission).
- Collaborates with other internal roles in country feasibility and site selection.
- Collaborates directly with the BMS internal study teams, external site staff, country ethics committees/IRB to ensure tasks and priorities are aligned to the defined study timelines
- Prepare country Informed Consent Form (ICF) and manage country ICF template
- Review translation and customize with requistes to obtain Site ICFs
- Review and approval of Clinical Trial Package (CTP) documentation
- Update national registries as applicable
- Ensures that the electronic Trial Master File (eTMF) contains the relevant Clinical Trial Package (CTP) regulatory documents for site activation and ongoing study management
- When applicable, conduct drug/IMP label review & translation
- Serves as expert on country regulatory requirements and keeps up to date with evolving regulation in collaboration with Regulatory and legal
- May support the collection and distribution of documents from / to sites including obtaining insurance certificates
- May support Health Authority inspection and pre-inspection activities
- May support audit preparation & Corrective Action / Preventative Action preparation for local related issues Senior Level Expectations:

- Serves as an SME for key investigational sites. Documents and maintains relevant information on the site’s structure, start-up processes, key contacts, etc (i.e., Site Playbook) for sharing with internal team members.
- Represents BMS in local (e.g. pharma association or HA driven) working groups around start up processes in the country
- Represents BMS in meetings discussing local requirements / repetitive questions from local Health Authority and Ethics Committees
- Proactively works with stakeholders (e.g. document template owners, GRS, CMC, CSO) to prevent questions from HA based on observed past questions.
- Constantly analyze the SSU process, looking for innovative ways to introduce efficiencies in order to speed-up start-up timelines, whilst maintaining quality.

**Requirements**:

- Bachelor's degree required preferably within life sciences or equivalent
- 5 years or more of industry related experience that includes significant experience in coordination of trial start-up activities and support to Health Authority / Ethic Committee submissions
- Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives Experience in leading or participating as an active member of cross functional teams, task forces, or local and global initiatives
- Thorough understanding of GCP, ICH Guidelines and Country regulatory environment
- In depth knowledge and understanding of clinical research processes, regulations and methodology
- Demonstrated organizational and planning skills and independent decision-making ability
- Strong organization and time management skills and ability to effectively manage multiple competing priorities
- Ability of critical thinking and risk analysis.
- Good verbal and written communication skills (both in English and local language)
- Knowledge of: Microsoft Suite / Clinical Trial Management Systems(CTMS) / Electronic Trial Master File (eTMF) / Document exchange portals

LI-hybrid

**Uniquely Interesting Work, Life-changing Careers**

**On-site Protocol**
Phy

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