Clinical Trial Coordinator II - Client Dedicated - Boston, MA

Submission for the position: Clinical Trial Coordinator II - Client Dedicated - Boston, MA - (Job Number: 172149)We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.  

Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:

Work on Clinical Trials by assisting the Clinical Trial Manager(s) (CTM) with the conduct of the assigned clinical trial(s) (administration, coordination, archiving)

Assist the Clinical Operations Lead (COL) with organizing the Clinical Team Meetings

Help the Head of Clinical Operations with the development of template documents to be used within the Department as well as with the logistics of the departmental meetings

Essential Functions:

Assist the CTM with the coordination of the logistical aspects of the assigned trial(s), according to Good Clinical Practice (GCP) and the applicable Standard Operation Procedures (SOPs)

Assist with signature collection for CDAs, contracts, POs and insurance certificates in collaboration with CTM/Director Vendor Management

Develop and adapt documents to trial specific requirements in collaboration with the CTM

May assist with the preparation of trial reports for the trial team and keeping them up-to-date

Assist with organizing (agenda, meeting minutes, follow-up on action items) trial specific meetings, including but not limited to trial team meetings, Investigator Meetings.

Assist the CTM/COL to ensure that the essential Trial Documents at sponsor level are properly filed and made ready for archiving. Provides input to the other departments outside Clinical Operations to ensure that the needed documents are filed within the (e)TMF.

Assist in (electronic) Trial Master File review (TMF) to confirm completeness and follow-up of findings.

May assist COL with the organization of the clinical team meetings (agenda, meeting minutes, follow-up on action items).

Help the Head of Clinical Operations with:

- The development of template documents to be used within the Department

- The organization of the departmental meetings (agenda, meeting minutes, follow-up on action items)

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.  

Our global Clinical department consists of colleagues with institutional knowledge, in-depth therapeutic experience, and robust operational tools. Together, we help clients define and develop clinical programs, minimize delays and execute high-quality, cost-efficient clinical studies.

At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and wellbeing of our employees.

Summarized Purpose:

Work on Clinical Trials by assisting the Clinical Trial Manager(s) (CTM) with the conduct of the assigned clinical trial(s) (administration, coordination, archiving)

Assist the Clinical Operations Lead (COL) with organizing the Clinical Team Meetings

Help the Head of Clinical Operations with the development of template documents to be used within the Department as well as with the logistics of the departmental meetings

Essential Functions:

Assist the CTM with the coordination of the logistical aspects of the assigned trial(s), according to Good Clinical Practice (GCP) and the applicable Standard Operation Procedures (SOPs)

Assist with signature collection for CDAs, contracts, POs and insurance certificates in collaboration with CTM/Director Vendor Management

Develop and adapt documents to trial specific requirements in collaboration with the CTM

May assist with the preparation of trial reports for the trial team and keeping them up-to-date

Assist with organizing (agenda, meeting minutes, follow-up on action items) trial specific meetings, including but not limited to trial team meetings, Investigator Meetings.

Assist the CTM/COL to ensure that the essential Trial Documents at sponsor level are properly filed and made ready for archiving. Provides input to the other departments outside Clinical Operations to ensure that the needed documents are filed within the (e)TMF.

Assist in (electronic) Trial Master File review (TMF) to confirm completeness and follow-up of findings.

May assist COL with the organization of the clinical team meetings (agenda, meeting minutes, follow-up on action items).

Help the Head of Clinical Operations with:

- The development of template documents to be used within the Department

- The organization of the departmental meetings (agenda, meeting minutes, follow-up on action items)

Education and Experience:

Bachelor’s degree or University degree – medical or para-medical or equivalent by experience

Minimum of 3 years of experience in similar position within Clinical Operations

Biotech experience is a plus

Knowledge, Skills and Abilities:

Speaks and writes English fluently - Dutch fluency is a bonus

Knowledge of ICH-GCP

Knowledge of (e)TMF

Proficient in software applications such as Outlook, Word, Excel and PowerPoint

Experience with tools and systems for managing clinical trials such as MS project, trial progress and metric systems, eCRF, IXRS.

Working Environment: PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role: 

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. 

Able to work upright and stationary for typical working hours.  

Ability to use and learn standard office equipment and technology with proficiency. 

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.  

May require travel.  (Recruiter will provide more details.)

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD –

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you

Education and Experience:

Bachelor’s degree or University degree – medical or para-medical or equivalent by experience

Minimum of 3 years of experience in similar position within Clinical Operations

Biotech experience is a plus

Knowledge, Skills and Abilities:

Speaks and writes English fluently - Dutch fluency is a bonus

Knowledge of ICH-GCP

Knowledge of (e)TMF

Proficient in software applications such as Outlook, Word, Excel and PowerPoint

Experience with tools and systems for managing clinical trials such as MS project, trial progress and metric systems, eCRF, IXRS.

Working Environment: PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.  Below is listed the working environment/requirements for this role: 

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner. 

Able to work upright and stationary for typical working hours.  

Ability to use and learn standard office equipment and technology with proficiency. 

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.  

May require travel.  (Recruiter will provide more details.)

PPD Defining Principles:

- We have a strong will to win - We earn our customer’s trust - We are gamechangers - We do the right thing - We are one PPD –

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, then please submit your application – we’d love to hear from you

Submission for the position: Clinical Trial Coordinator II - Client Dedicated - Boston, MA - (Job Number: 172149)