Purpose

SyMetric is in the business of providing Products/Services in the Clinical Research Domain. We engage with Pharmaceutical Industry representatives, Contract Research Organizations (CROs), Drug Logistics Handling agents, Investigation Sites (popularly known as Hospitals and Medical Research Centers), etc. As part of our service delivery, we are looking for experienced personnel, who can manage the customer projects independently with least supervision from the Management.

Job Details

Job Code: ASPL/JD/PM/CDM/APM
Contract Type : Regular / Full Time
Job Location: Bangalore
Travel Expectations: 10%
Contact Info: [email protected]

Roles and Responsibilities

- Project Management and Clinical Data Management for the given Project.
- Project management includes handling customer projects that include systems and services for IWRS/EDC/CTMS
- Customer Management for the given Project
- Monitor the Project Timelines and take necessary action to keep the project on track.
- Responsible for all the Project deliverables towards the customer project
- Act as a point of contact from SyMetric
- Provide clinical data management support to Clinical Operation Team/Sponsor/ Customer and Clinical Data Management Team
- Review of all the Clinical Data Management Documents (e.g. Protocols, Case Report Forms (CRFs), Reports)
- Develops Data Management Plan (DMP)
- Develop Electronic Case Report Form (eCRF)
- Create project specification documents, including eCRF design, user requirements, edit checks, Business rules, and data validations
- Coordination of User Acceptance Test (UAT) of eCRF build and validation documents included but not limited to: edit check document, eCRF Filling Instruction, UAT summary report




- Assist AE/SAE Data Reconciliation in Safety DB and/or SyMetric CDM Database, including but not limited to, performing MedDRA and/or WHO coding
- Develop Plans for Data Quality in EDC to Database Lock/Unlock, Data Freeze / Unfreeze for Data Review, and Final Database Lock
- Perform close-out audit, as specified, for the closing of study trial in SyMetric Clinical Data Management Databases
- Ensure 100% compliance to SyMetric SOPs

Technical Skills

- Microsoft Office Suite
- Clinical Data Management System (CDMS) skills
- Having Knowledge of Positive Clinical Practice (GCP), Good Clinical Data Management Practice (GCDMP), CDISC, CDASH, and Regulatory Requirement(21 CFR PART 11)
- Working Knowledge of Clinical Database applications (e.g. Electronic Data Capture (EDC, IWRS ), Clinical Data Management System (CDMS)
- Understanding Incident Management, Clinical Data Management, and Clinical Trials monitoring experience is highly desirable

Competencies

WORK EXPERIENCE

- 4+ years of experience in handling projects in Clinical Data Management for clinical trial projects or health sciences-related projects.
- Working in an IT environment is essential.
- Pharma Industry Knowledge (preferable)
- Individuals who handled projects in Pharma Industry, CROs will be given preference. Experience in working on IWRS/EDC systems is preferred

COMPETENCIES

- Strong Intercultural Awareness
- Strong Communication Skills in English
- Time Management
- Working in Virtual Teams where needed

EDUCATION AND OTHER QUALIFICATIONS

- Ideal Candidate should possess a Postgraduate or bachelor’s degree in any faculty, preferably in Pharmacy
- Specialization in Clinical Data Management methodologies is essential.
- IT Service management skills are preferred

📌 Asst. Project Manager (India)
🏢 SyMetric Systems
📍 India