Clinical Data Associate

.

**The Company**

BioPharma Services Inc. is a subsidiary of Think Research.

BioPharma Services was founded by two surgeons dedicated to advancing medical science to improve the life and spirit of their patients. With this same dedication and vision in mind, these physicians brought life to BioPharma.

Through each success, and even some failures, the perpetual drive to make BioPharma great has been determined by the will and dedication of our people. The will to empower their colleagues, friends and teammates to excel in all facets of clinical research and inspire performance to achieve greatness.

It is with this same culture and brand of excellence that we welcome our clients. To experience the team community that has propelled us into a global leader in medical research, to be a client-focused partner, where people and patients matter.

Again, we invite you to come and meet our people. Our people who have learned that success is better achieved and celebrated as a team than as an individual.

**Why Us?**
- It's not every day that you have the chance to change the way your friends and family are cared for - Make an impact
- Everything we do - and we do it with passion - is to improve the quality of life for patients who benefit from the clinical trials that we perform for global pharmaceutical companies.
- We’re growing, and so will you with leaders who will support your development through mentorship and other opportunities
- Collaborative, creative, dynamic and flexible work environment, with a start-up spirit

**The Role**

The Clinical Data Associate, working with senior data management members, is

responsible for entering clinical study data into an electronic database(s), setup

databases, data cleaning/query management and documentation of clinical study

databases and clinical data for clinical studies to current regulatory and industry

expectations and standards.

**You Will Have The Opportunity To**:

- Perform assigned activities related to data management per regulation and applicable standard operation procedures (SOPs)
- Contributes to the development and testing of study specific databases and clinical study data for mainly Phase I and BA/BE clinical studies and potentially for Phase II-IV clinical studies
- Editing, processing (data entry) and entry of data into an electronic database from relevant clinical study documentation (e.g., Case Report Forms, Source Documentation)
- Resolution of database queries, as generated in real-time or following completion of all planned data entry
- Quality control review of entered clinical trial data to ensuring accurate and precise entry of all data
- Identifying issues and queries with study documentation and bringing this to the attention of the direct supervisor (or designate)
- Adherence to study timelines
- Performing all work in accordance with BSPI Standard Operating Procedures, relevant regulatory guidelines and study requirements
- Involved in the management of the process from DMP development to data entry, data cleaning and data transfer
- Contributes to or writes the Data Management Plan (DMP) and other data management documentation
- Design and review eCRFs according to the study protocol, set up database, perform user acceptor testing (UAT) and lock database and study data
- Performs quality control (QC) on study data as needed
- Create, review, and process data queries and updates the database
- Query data inconsistencies and revise case report forms in compliance with SOPs, client guidelines and regulatory agency guidelines
- Other duties and responsibilities as required

**What You Will Bring**:

- BA or BS with a science or related background; equivalent experience in data
- management and a medical-related field may be substituted
- Experience in data entry or Data Management activities, performing activities in relationship to set up, conduct and locking of clinical data
- Understanding of database structures and database programming
- Knowledge of CDISC standards, especially CDASH and SDTM
- Knowledge of clinical trial processes and experience in, ICH GCP, and GCDMP
- (SCDM)
- Strong analytical and problem solving skills
- The ability to multitask and prioritize are essential
- Strong oral and written communication skills
- Self-motivated, with the ability to learn quickly and independently
- Think Research and all subsidiaries are proud to be an equal opportunity employer and is committed to creating a diverse and inclusive workplace, free of discrimination and harassment._
- We provide equal employment opportunities (EEO) to all employees and applicants regardless of race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status._
- We are committed to providing accommodations for people with disabilities. Should you require an accommodation, we would like to work with you to meet your needs._

3mTiRm52DG