Data Quality

CLINICAL DATA ASSOCIATE II/ LEAD CDA

Evgeniy Shpuntov, BSc

EDUCATION

BSc, IT and English, 2012

Physics and Mathematics Faculty, Smolensk State University, Smolensk, Russia

THERAPEUTIC EXPERIENCE

Oncology: Other malignant neoplasms of lymphoid and histiocytic tissue; Antineoplastic, unclassified

therapeutic agents; Lung neoplasm/Cancer, Non-small Cell Lung Cancer; CNS tumors (Brain)/Neoplasms

Neurology: CNS tumors (Brain)/Neoplasms

Injury/Poisoning: Complications of medical care, not elsewhere classified.

Endocrine System: Disorders of adrenal glands.

Hematology: Antineoplastic, unclassified therapeutic agents.

Respiratory: Respiratory neoplasm/Neoplasms, Bronchial, Respiratory/Respiratory

neoplasm/Neoplasms, Lung; Asthma

Circulatory: chronic obstructive pulmonary disease (COPD)

PROFESSIONAL EXPERIENCE

PPD, Smolensk, Russia Clinical Data Associate II/ Jan 2013-present

Lead CDA

Clinical Data Associate II/ Lead CDA:

Perform advanced aspects of the data cleaning process, with a high degree of accuracy and in

accordance with GCPs and SOPs/WPDs. Key responsibilities are Data Listing reviews, and reconciliation

of Serious Adverse Events and Third Party Vendor data, generating study metrics for sponsor

review/providing feedback to the team; perform study set-up activities including eCRF design, EECs

Specifications writing/testing, PDs testing, eCRF Completion Guidelines.

Act as key team player on reaching Study deliverables like monthly data transfer, IA cut-off and Database

lock coordinating and assigning tasks to be performed under timelines, existing procedures and

appropriate quality.

Collaborate across several departments and teams, actively provide support on specifics of cross

department functions having thorough understanding of processes. Initiate trainings for individuals and

team in terms of reaching high level of performed activities and data quality. Liaise with CRAs to increase

quality of eCRF completion and resolve existing issues in proactive manner, to help avoid potential

discrepancies.

Detailed experience overview:

Evgeniy Shpuntov, BSc Page 2 of 4

• Query review/processing and Data listings review on assigned projects according to timelines and

quality expectations from Sponsor.

• Perform/coordinate QC and attending Query Review meetings with Sponsor to identify data

quality in accordance to Edit Checks/Data frequency listings.

• Perform/coordinate SAE Reconciliation, TPV/LAB Reconciliations (IVRS, ECG, PK, ADA etc.) in

accordance with VAP and update existing VAP to ensure all study specific procedures are

accurate and up-to-date with Protocol.

• Organize 1st and 2nd Pass Entry of PDs/LNRs when required.

• Handle Batch Validation sessions to ensure Edit Check validation is an ongoing process and up-

to-date with frequent eCRF data entry.

• Create EECs Specifications/RPS.

• Test EECs/PDs.

• Create eCRF Completion Guidelines.

• Create Study Specific metrics for Sponsor review and provide feedback on existing data points.

• Attend Sponsor/Vendor meetings acting as active project team member, escalating existing

discrepancies and potential gaps in timelines, actively seeking for a solutions.

• Provide guidance and mentor team members for both standard activities (SAE/TPV

Reconciliations, UAT, RPS) and study specifics.

• Create and review Monthly Task Planner and provide feedback to the team;

• Overview and assign tasks according to Data Management Plan and Monthly Task Planner.

• Archive Clinical Study Data in accordance to CRO DM Administrative file to ensure all study

documentation is filed on post lock.

MTS Group, Smolensk, Russia SMD Specialist Aug 2012-Dec 2012

(non CRO position)

• Service maintenance.

• Clients budget control.

• Managing client budget rates within the system.

• Liaising with client’s personal managers.

• Computer processing of customer requests.

ACHIEVEMENT & ACCOMPLISHMENTS

PPD, Smolensk, Russia Clinical Data Associate II/ Jan 2013-present

Lead CDA

Dates: January 2013 – June 2013

• Being the first member of new hiring wave rapidly learned basic and advanced DM activities and

continued both personal and team development by mentoring/guiding second wave staff. Initiated

team training in UAT which was necessary for upcoming number of trials in set-up phase that was

beneficial for local DM staff.

Printed: 03/09/15 Revised: 03/09/15

Evgeniy Shpuntov, BSc Page 3 of 4

Dates: November 2013 – January 2014

• Cross-functional review organization, having lack of resources prior IA Cut-off took lead role to

overview the process of key Listings review and Reconciliation. Being expert and having thorough

understanding of study specifics helped to perform full review with high data quality and

according to expected timelines.

Dates: February 2014 – present

• During frequent staff changes on a study took lead role on coordinating and overviewing study

activities, mentoring staff on regular basis, actively providing feedback to the team which helped

to stay within approved timelines and deliver high quality of data.

Dates: November 2014 – December 2014

• During DB lock on assigned study was the one who left on a study from key staff performing DB

lock activities due to staff changes. Actively communicated with sponsor in regards to performing

activities completed from DB finalization to Data archival with high quality and attention to details

which helped to lock study according to agreed timelines.

PROFESSIONAL DEVELOPMENT

• Training while employed at PPD is available upon request.

• Primary training course “Good Documentation Practice”

• Primary training course “21 CFR Part 11”

• Basic CDISC course while employed at PPD

COMPUTER EXPERIENCE

Windows 7, MS Word, MS Access, MS Powerpoint, MS Outlook, Oracle Clinical Version 4.6, Medidata

Rave, Query Direct, LiveLink Enterprise System 9.2, Oracle MySQL 5.5, MSSQL.

LANGUAGES

Mother tongue: Russian.

Proficient: English.

CLINICAL TRIAL EXPERIENCE

Clinical trial experience while employed at PPD:

CDA II/ Lead CDA

• Oncology: A Randomized Controlled Double-Blind Phase III Trial to Compare Efficacy and Safety of a

Monoclonal Antibody and another Monoclonal Antibody in Combination with Chemotherapy Regimen

in First-Line Treatment of Advance-Stage Follicular Lymphoma.

Printed: 03/09/15 Revised: 03/09/15

Evgeniy Shpuntov, BSc Page 4 of 4

• Oncology: Phase II Study of a XXXX Inhibitor in Patients with Relapsed and Refractory Non-Hodgkin

Lymphoma.

• Injury/Poisoning: Phase II Open-Label Single-Arm Multi-center Study to Evaluate the Efficacy and

Safety of an Iron Chelator in Combination with a Test Drug Followed by an Iron Chelator Monotherapy

in Patients with Severe Cardiac Iron Overload Due to Chronic Blood Transfusion.

• Endocrine system: A Randomized Double-Blind Multi-center Phase III Study to Evaluate the Efficacy

and Safety of Test Drug LAR in Patients with Cushings Disease.

• Oncology/ Respiratory: A Randomized, Multicenter, Open-Label Phase 3 Study of Chemotherapy Plus

an Anti-body Versus Chemotherapy Alone in the First-Line Treatment of Patients With Nonsquamous

Stage IIIb or IV Non-Small Cell Lung Cancer (NSCLC)

• Circulatory: A randomised multi-centre, double-blind, double-dummy, two way cross-over, twelve

weeks noninferiority study to evaluate the efficacy, safety, and tolerability of combination XXX and

XXX twice daily delivered through a capsule-based inhaler and a multi-dose inhaler for the treatment

of chronic obstructive pulmonary disease (COPD).

• Diseases of the respiratory system: A multi-centre, randomised, double-blind, double-dummy, two

way cross-over, twelve weeks non inferiority study to evaluate the efficacy, safety and tolerability of

combination XXX and XXX twice daily delivered through a capsule-based inhaler and a multi-dose

inhaler in adults and adolescents with asthma.

• Oncology: A randomized open-label, single dose cross-over study to investigate the bioequivalence of

three XXXXX test formulations versus a reference formulation following oral administration in healthy

subjects.

• Neurology/Oncology: A Phase I Study of an Anti-neoplastic in Combination with Standard

Radiotherapy Plus Concomitant Alkylating Agent which Followed by Adjuvant Anti-neoplastic with

Alkylating Agent in Patients with Newly Diagnosed Glioblastoma Multiforme

• Oncology/Hematology: A Multi-center, Open-Label, Non-Controlled Phase II Study of an

Antineoplastic in Pediatric Patients with Newly Diagnosed Ph+ Chronic Myelogenous Leukemia

(CML) in Chronic Phase (CP) and with Ph+ CML in CP or Accelerated Phase (AP)

Resistant/Intolerant to Either an Antineoplastic or Another Antineoplastic

All Study activities are based on PPD and Sponsor specific SOPs/WPDs, also

according to the GCP and GDP.

Contact details

Mobile phone number: +7-919-***-****

E-mail: ********.****@*****.***

Printed: 03/09/15 Revised: 03/09/15

Contact this candidate