Site Monitoring Plan Specialist (m/f/d)

Bristol-Myers Squibb

Boudry

vor 5 Tg.

At Bristol Myers Squibb, we are inspired by a single vision transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change.

We bring a human touch to every treatment we pioneer. Join us and make a difference.

The Site Monitoring Plan (SMP) Specialist drives SMP content development and excellence. Acts as the RCO functional representative for Data Management Review Plans, providing input to ensure data integrity and completeness.

Key Responsibilities and Major Duties

Serves as the study level global RCO representative for monitoring providing input into the Risk Assessment and other critical study level plans including :

DQMP (Data Quality Monitoring Plan)

PDRP (Protocol Data Review Plan)

CMSP (Centralized Monitoring Strategy Plan)

DLP (Database Lock Plan)

PDAP (Protocol Deviation Assessment Plan)

SMP (Site Monitoring Plan) Authoring and Management :

Drive SMP content excellence, by providing study-specific and detailed guidance for monitoring sites, including on-site and off-site monitoring expectations

At start-up develop and write the study specific SMP and maintain it for the life of the study

Create RBM monitoring execution slide-deck and update for the life of the study

Develop SPSD (Site Process and Source Documentation) Form and update for the life of the study

Perform the TSDV specifications quality control check (RAVE), review and approve the TSDV specification in the study Trial Master File.

Attend the relevant study level meetings to support SMP creation, including RACT protocol meeting and Data Review Strategy meeting (e.

g. to understand the critical data requiring SDV)

Support study related RBM questions

Participate in inspections as needed

Management of Targeted Source Data Verification (TSDV) in the Electronic Data Capture (EDC) system at a study level. May include block / tier changes, subject include, override, and run retrospective triggered by RACT risk level changes, changes to critical data, post productions changes, etc.

Disclaimer : The responsibilities listed above are only a summary and other responsibilities will be requirements as assigned)

Key Stakeholders / Contacts describe this position’s key internal matrix relationships and key external stakeholders / clients

Stakeholders within the RCO Clusters

Stakeholders within Global Development Operations

R&D Quality

List of minimum requirements

Degree / Certification / Licensure

Bachelors degree required preferably within life sciences or equivalent.

Experience Responsibility and minimum number of years

At least 3 years of robust site monitoring experience

Prior data management quality review experience preferred

Competencies knowledge, skills, abilities, other

Knowledge of ICH / GCP Guidelines and applicable local laws and regulations (Health Authorities) which govern clinical trials.

Knowledge and understanding of clinical research processes, regulations and methodology

Understands clinical landscape with practical knowledge of a variety of medical settings and medical records management

Organization and time management skills.

Ability to build, maintain and strengthen relationships even under pressure and / or in difficult situations

Good verbal and written communication skills (both in English and local language).

Software that must be used independently and without assistance (e.g., Microsoft Suite)

Microsoft Suite

Clinical Trial Management Systems(CTMS)

Electronic Data Capture Systems (eDC)

Electronic Trial Master File (eTMF)

Working Conditions

Travel Required (nature and frequency) : Minimal

Overnight Absences Required (per typical month) : 0-1

Describe exposure to any hazards / disagreeable conditions in the work environment : Ergonomic

Office based or Remote by Design : Remote by Design

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

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