Inci Gunes

MSc
Clinical Project Manager

About Me
Contact
I’m super passionate healthcare professional with 11 years experience working in the healthcare
industry including hospital engagement, clinical research, clinical traning/managing as well as
biotech settings.
inci.gunes19@gmail.com Have ability to create, innovate and analyze work life situations and daily routine circumstances,
coordinate enthusiasm and confidence with a good decision making in addition to
+905353405469 creativity&persuasion.
In short terms, catching a value adding career opportunity in the light of my education and
career background. In long run, adding value to the company and working, strategic foreseeing
Kartal-Istanbul of my future career via getting all needed skills and practices.

Education
Work Experience
Master's Degree
CLINICAL PROJECT MANAGER
Acibadem University, Institute of
Health Sciences Koç University Hospital-Clinical Trials Center | December 2023-
Surgical Nursing Thesis:
Evaluation of Knowledge and Practices of The Develop and implement comprehensive project plans for early phase
Nurses on Preventing Surgical Site Infections oncology clinical trials.
2018-2020 Collaborate with cross-functional teams to define project goals,
Bachelor's Degree timelines, and resource requirements.
Contribute to the development of overall clinical development
Acibadem University, Institute of Health strategy.
Sciences Identify potential risks and issues related to clinical trial conduct and
Nursing/ %100 schloraship develop mitigation plans.
2009-2013 Focus on the operational integrity and feasibility of individual studies
utilizing a variety of resource solutions to ensure the most effective,
Skil l s efficient, and high quality study is designed and executed.
Proactively address and resolve challenges to ensure the successful
execution of clinical programs.
Effective Communication
Oversee the day-to-day management of clinical trials, ensuring
Project Management adherence to protocols, timelines, and budgets.
Coordinate and communicate with clinical investigators, CROs, and
Critical Thinking
other study vendors.
Problem Solving Manage study start-up activities, site initiation, and monitoring
activities.
Clinical Research Collaborate with regulatory affairs to ensure timely submission of
Decision Making regulatory documents and compliance with regulatory requirements.
Contribute to the preparation of regulatory submissions and responses
Risk Assessment to regulatory authorities.
Foster effective communication and collaboration with internal and
Time Management
external stakeholders, including clinical development, regulatory
affairs, pharmacovigilance, and external partners.
Language
Lead and manage clinical trials focused on variety of therapies,
ensuring adherence to protocol, regulatory requirements, and
Turkish: Native timelines.
English: Advance Forms successful relationships with Sponsors/CRO’s through clear
communication and defined expectations.
 Work Experience
SITE NETWORK ENGAGEMENT MANAGER
EASTERN EUROPE&MIDDLE EAST
Clinerion/TriNetX Health Data Companies | Jan 2023- Oct 2023
Identify potential projects and initiate engagement with key contacts at our hospitals.
Regular communication with key sites to connect on all trials/all stages to determine trends
and opportunities and enhance site’s experience with pharma companies.
Ensures that required essential documents are complete and in place according to ICH-
GCP and applicable regulations.
Contact Conducts on-site file reviews as per project specifications.
Ensure the protection of study patients by verifying that informed consent procedures and
inci.gunes19@gmail.com
protocol requirements are adhered to according to the applicable regulatory requirements.
Supports allocation activities per the local resourcing process. Supports activities of
+905353405469
project leads/functional leads to optimize the operational running of projects.
Kartal-Istanbul
Ensures all staff CVs, training records, position profiles and experience profiles are
complete and up-to-date. Ensures timeliness and accuracy of timesheets and expense
Education reports.
Facilitates effective communication between investigative sites, client company and
Master's Degree
internal project teams through written, oral and/or electronic contacts.
Acibadem University, Institute of
Health Sciences Responds to company, client and applicable regulatory requirements/audits/inspections.
Site selection, pre-trial assessment,
Surgical Nursing Thesis: subject recruitment and retention planning, site
Evaluation of Knowledge and Practices of The
Nurses on Preventinginitiation,
Surgical Site monitoring
Infections and close-out.
2018-2020
Ensure that compliance with the applicable SOPs, quality documents and guidelines,
Bachelor's Degree
protocol and amendments is maintained by the CRAs/RAs during the project.
Acibadem University, Institute
Develop, of Health
drive and monitor site operational strategies and performance across all
Sciences
therapeutic areas and studies, in strong collaboration with stakeholders.
Nursing/ %100 schloraship
2009-2013 Acting as the Assigned Protocols subject matter expert. Develop strong therapeutic
knowledge to support roles and responsibilities.
Skil l s
Develop SOPs on how trials are approved within our hospitals when external pharma
and/or CROs bring them.
Effective Communication
Provide input into and/or develop study related materials such as Clinical Monitoring Plans,
Advance Presentation
Data Management Plans, eCRF forms and completion guidelines.
Critical Thinking
Assist in negotiation of trial site contracts and budgets. Forecasts and handles local trial
Problem Solving
budget to ensure accurate finance reporting and trial delivered within budget. Adheres to
finance reporting results and timelines.
Clinical Research
Build and develop strong relationships with key sites to engage as Choice for clinical trial
Microsoft Office
participation, to effectively advance site operational engagement and better understand
Clinical Investigation Plan
current site processes to enhance clinical trial execution.
Clinical Evaluation Plan and Report
Align and lead identification and strategic partnership with key sites to implement a
collaborative initiative for clinical trial execution.
Language
Work on variety of projects (Rare Disease, CLL-oncology, Influenza, CVD).

Turkish: Native
English:
Advance
 Work Experience

CLINICAL RESOURCES CONSULTANT-MENA

BIOSURGERY/INFECTION PREVENTION

Becton Dickinson (BD) | Mar 2019- Sept 2022

Determines customers' needs and desires by specifying the research needed to obtain
market information.
Awareness and following of knowledge of applicable clinical research regulatory
requirements; Good Clinical Practice (GCP) and International Conference on Harmonization
(ICH) guidelines.
Contact Provide clinical support and work in close partnership with distributors and sales team.
Support the central feasibility teams with local insight to support country strategy,
inci.gunes19@gmail.com
protocol development and new business awards.
Provide accurate, timely and realistic information.
+905353405469
Work in close liaison with Marketing and Clinical (MENA) to obtain relevant market,
Kartal-Istanbul
product and clinical information and provide feedback to sales teams and/or customers.
And to understand healthcare re-imbursement, trial infrastructure, patient motivations,
Education patient support groups, site networks, new potential sites/Investigators for consideration
in your country, region, therapy area.
Master's Degree
Collect competitor information to build clinical strategy.
Acibadem University, Institute of
Health Sciences All clinical aspects of the portfolio within the assigned geography and provide pre- and
post-sales support in a clinical, training and educational capacity.
Surgical Nursing Thesis:
Evaluation of Knowledge and Practices of The
Nurses on PreventingBuild-up
Surgical Site close and effective partnership with reference sites and
Infections Key Opinion Leaders
2018-2020 (KOL).
Bachelor's Degree
Assesses market competition by comparing the company's product to competitors'
Acibadem University, Institute of Health
products.
Sciences
Make presentation to HCPs and developing/following
Nursing/ %100 schloraship Standard Operating Procedures and
2009-2013 adhering to company policies and safety guidelines.
Recommends the nature and scope of present and future product lines by reviewing
Skil l s
product specifications and requirements; appraising new product ideas and/or product or
packaging changes.
Effective Communication
Provides source data for product line communications by defining product marketing
Advance Presentation
communication objectives.
Critical Thinking
Obtains product market share by working with sales director to develop product sales
Problem Solving
strategies.
Provides information for management by preparing short-term and long-term product
Clinical Research
sales forecasts and special reports and analyses; answering questions and requests.
Microsoft Office
Attends and organizes educational programs for customers and communicate with
Clinical Investigation Plan
stakeholders related to marketing activities and follow up with the process.
Clinical Evaluation Plan and Report
Introduces and markets new products by developing time-integrated plans with sales,
advertising, and production.
Language
Determines product pricing by utilizing market research data; reviewing production and
sales costs; anticipating volume; costing special and customized orders.
Turkish: Native
English:
Advance
 Work Experience
INFECTION CONTROL NURSE
Acibadem Altunizade Hospital | May 2017 - Feb 2019
Conducted surveillance of infections, both community acquired and nosocomial.
Monitored compliance with state and local regulations JCI standards.
Reported and communicated findings to the Operations Manager.
Developed infection control procedures and evaluated outcome.
Assessed infectious conditions with patients, staff and the environment, and
implemented appropriate control measures.
Contact Established priorities for interventions according to risk to patient, staff and hospital.
Started the programs at a new facility (Acibadem Altunizade Hospital).
Surveillance, reporting and education to prevent and minimize nosocomial infections in
inci.gunes19@gmail.com
the hospital.
+905353405469
Policy development and review. Follow-up with education and compliance.
Kartal-Istanbul
New hire orientation and immunization. Training and supervision.

Education
HOME CARE SERVIS COORDINATOR

Master's Gulaylar
Degree Group | Feb 2016 – Apr 2017
Participated
Acibadem University, as a part of an interdisciplinary team to develop care plans for new
Institute of
Health Sciences members, and in assisted in determining appropriate changes in the care plans of
Surgical Nursing Thesis:
continuing members to meet theiunique individual needs.
Evaluation of Knowledge and Practices of The
Nurses on PreventingProvided
Surgical Sitetraining,
Infections supervision, and guidance to member assistants.
2018-2020
Facilitated in the resolution of member grievances. Submitted requests for the scheduling
Bachelor's Degree
of services determined medically necessary by the interdisciplinary team.
Acibadem University, Institute of Health
Assisted in the assignment of home care visits as needed. Created and updated
Sciences
telephone care plans
Nursing/ %100 schloraship as needed to assure that member assistants provide appropriate
2009-2013 care at each visit.

Skil l s INTENSIVE CARE UNIT(ICU)-TEAM LEADER NURSE

Acibadem Taksim Hospital | Jun 2015 – March 2016
Worked closely with interdisciplinary team to assure excellent communication and patient
satisfaction.
Mentored and motivated members of team to complete higher education and career
development.
Accountable for ensuring quality patient care through direct supervision of all nursing
personnel assigned to the unit.
Demonstrated knowledge, judgment, expertise and managerial skills to ensure smooth
functioning of unit on a 24 hour basis.
Serve as liaison, resource and educator for other hospital departments integrated into the
organization& overall operation.
LanguageProtect patients, families, employees, and visitors by adhering to and maintaining infection
control policies and protocol.
Turkish: Native
Initiate weekly multidisciplinary patient rounds and team collaboration of patient goals with
English: significantly improved outcomes.
Advance Achieved highest rated (97%) Customer Satisfaction within hospital as a result of unit based
initiatives.
 Work Experience

INTENSIVE CARE UNIT(ICU)-NURSE

Acibadem Maslak Hospital | Feb 2012 – Jun 2015
Set up, operate, or monitor invasive equipment and devices such as endotracheal tube and
tracheotomy equipment, mechanical ventilators, catheters, central lines, nasogastric and
orogastric tubes.
Perform administrative duties that facilitate admission, transfer, or discharge of patients.
Distinguish between normal and abnormal developmental and age-related physiological and
behavioral changes in acute, critical, and chronic illnesses.
Contact
Manage patients; pain relief and sedation by providing pharmacological and non-
pharmacological interventions, monitoring patients; reactions, modifying as needed.
Document data related to patients; care including assessment results, interventions,
medications, patient responses, or treatment changes.
+905353405469
Administer blood and blood products transfusions, and monitor for adverse reactions.
Kartal-Istanbul
Wound care/repositioning as required.
Suctioning as required adjusting ventilator/IABP as required dealing with family/visitors - lots
Educationof teaching about monitors etc.
Organizing and transporting if tests such as CT required.
Master's Degree
Acibadem University, Institute of
Health Sciences
Surgical Nursing Thesis:
Evaluation of Knowledge and Practices of The
Nurses on Preventing Surgical Site Infections
2018-2020

Bachelor's Degree
Acibadem University, Institute of Health
Sciences
Nursing/ %100 schloraship
2009-2013

Skil l s
Effective Communication

Advance Presentation

Critical Thinking

Problem Solving

Clinical Research

Microsoft Office

Clinical Investigation Plan

Clinical Evaluation Plan and Report

Language

Turkish: Native
English:
Advance
 Awards

BD Company Leadership Standards Award Program- Silver Award

Seminars and Courses

Design and Conduct of Clinical Trials- Johns Hopkins University, 01.09.2023

Clinical Trials Analysis, Monitoring, and Presentation- Johns Hopkins University, 06.07.2023
Good Clinical Practice - Novartis, 05.06.2023
Data Management for Clinical Research- Vanderbilt University, 11.07.2022
P.O.C Summit/ Germany, 02.2020
IP Summit / Turkey, 12.2019
Way of Selling / Sale Tools /Turkey, 10.2019
IP Summit /Dubai, 04.2019
English Course / San Diego, 09.2018
Hospital Infections Congress /Turkey- Surveillance Course in Infection Control, 04.2018
Acibadem Health Group-Medical Waste Education Authorization Certificate, 07.2017
Acibadem Health Group-Clinical Nursing Education Candidate Training Program, 02.2016

References
Yeliz Kanlıcalıoğlu

Becton Dickinson / Sales and Marketing Manager

Phone: +905304551432

Prof. Dr. Sesin Kocagöz

Acibadem Altunizade Hospital / Chef Physician

Phone: +905326257667