- Assists and provides support to the members of the clinical operations study team in administrative activities in order to facilitate the overall management of Company sponsored studies
- Executes tasks as assigned by the CPM related to the conduct of clinical studies, study budget forecasting and tracking
- Responsible for collecting, tracking and supports reporting of research related Transfer of Value (TOV) to enable compliance with Transparency reporting requirements (US and EU)
- Responsible for ensuring study documentation (including trial master files, study related contracts and financial level documentation) and study documentation is processed, maintained/archived in compliance with ICH-GCP, Company policy and procedures. Includes liaison with service providers in regards Ipsen e-TMF process and resolving issues related to missing documentation
- Performing QC checks on TMFs to ensure completeness and readiness for audit/inspection
- Contributes to clinical trial excellence initiatives
- In charge of the Ipsen electronic TMF (and/or paper TMF, if applicable) set-up and administration.
- Manage the clinical study creation and set-up for the country and site binders and the trial milestones.
- Prepare and customize the TMF Oversight plan, TMF Management plan, TMF master index & business rules, according to the clinical study specificities with the CRM/CPM and the Document Owners.
- Inform the appropriate role of all study team members (CRO/Ipsen) newcomers or departure.
- Ensure the TMF is being maintained up-to-date and all essential documents are appropriately filed in the TMF.
- Perform continuous oversight of the CRO/Ipsen TMF activities, in checking the documents consistency and the respect of the SOP timelines to maintain the TMF data integrity and by communicating this oversight status to all relevant Ipsen study team members.
- Coordinate the TMF Quality Check (per Ipsen SOP) with the CRO/Ipsen to ensure the eTMF inspection readiness.
- Coordinate the final TMF reconciliation with the CRM/CPM.
- In charge of archiving the TMF
- Create and update financial information within the Ipsen financial K2 system (Internal Order, Purchase Order, goods receipt & invoices), if not managed by a dedicated position within the team
- Create and follow-up of the clinical study Commitment Requests within the Ipsen dedicated tool (K2)
- Create and update the specific clinical study budget trackers
- Review invoices against CRO/Vendor contracts and study progress to provide recommendation of approval or not to the CRM/CPM
- Follow up of the clinical study invoices to secure payments in time. Support, if necessary, the CRM/CPM in the clinical study budget such as forecast preparation, attendance to quarterly review meetings ...
- Collect all the information related to reportable transfers of value (ToV) to Healthcare Professionals (HCPs) & Healthcare Organizations (HCOs) in the Group Transparency system (Collect)
- Ensure the complete data tracking by the CROs with the Data Collection Template (DCT), organize presentation of the instructions to the CROs if needed.
- Check the data received from the CROs with the support of the CRM/CPM
- Ensure the information is properly recorded in the COLLECT system, implement corrective actions where needed
- Ensure the Transfers of value collected (directly or via the CROs) in COLLECT are validated along the way in compliance with the disclosure timings requirements.
- When needed, create new HCP/HCO records in the COLLECT system
- Where applicable, check the disclosure consent of Healthcare Professionals (HCPs) for each activity
- When needed, liaise with the Local Transparency Manager (LTM) or the Global Transparency Manager (GTM) to ensure the mandatory information for HCPs & HCOs is tracked in the Transparency system
- When assigned on a study, get access to the study record in eCTMS
- Check the eCTMS study data using the Clinical Operations Reporting (i.e. Clinical Operations Dashboard, CSS Monthly Report) and update as applicable (at study/region/site level: status, study sites creation, study team/contacts, recruitment, study milestones tracking) with the support of CRM/CPM for the monthly report purposes
- Ensure the study team contacts and handovers are properly tracked in eCTMS
- Provide the excel tracker to the CRO together with instructions to get all the necessary information monthly to feed the Ipsen eCTMs (Hermès)
- Update the eCTMS with the CRO tracker information after validation with the CRM/CPM as per the CTMS user guide (at study, region and site level as applicable)
- Generate contract templates within the Ipsen dedicated system (i-CAP), follow-up until the clinical study contracts are signed and secure proper filing and archiving of all fully executed contracts
- Collect and follow-up of all legal administrative documents such as Power of Attorney (POA), Letter of Authorization (LOA), Confidentiality Disclosure Agreement (CDA), Kbis...
- Ensure insurance certificate and renewals are being requested prior to the study start-up and during the course of the study
- Coordinate the dispatch order for the clinical supplies if not managed by a dedicated system such as IVRS, meaning the collection of appropriate documents permitting to obtain import license and release study drugs
- Set-up and maintain shared study electronic site (SharePoint, box or other tools)
- Organise appropriate logistics for any Ipsen Sponsor meetings (invitation/room booking/lunch order...) such as Investigator's meeting, DRM & TFLs, Steering Committee, ...
- Attend all study team meeting when appropriate and take meeting minutes
- Perform any clinical study activity delegated by CRM/CPM such as the project management and monitoring of clinical studies, including liaison with monitors, CROs, drug vendors, central laboratories and other vendors
- Be active member of dedicated working groups to achieve clinical operation excellence and harmonization by updating/revamping processes
- Coordinate the writing of articles related to the clinical study or working groups to be posted in the monthly newsletter
- Provide support to the medical writer within the Clinical Study Report (CSR) to secure the collection of appropriate appendices such as investigators' Curriculum Vitae, list of Ethics Committee & List of participating investigators
- Comply with applicable EHS regulations and procedures.
- Participate in the site's EHS performance by reporting risks, malfunctions or improvements
- Participate in mandatory EHS training
- Ideal: experience in clinical study environment within CRO or Pharmaceutical company.
- Minimum: Knowledge of the clinical study environment with a strong theorical or practical administrative organization.
- Scientific background is an asset.
- Ideal: 3-year degree in a scientific, or clinical or research field and a 1 minimum of 1year relevant work experience in a clinical research/study management environment (academia or pharma or CRO).
- Minimum: 2-year relevant scientific focused degree and a minimum of 2 years relevant work experience within clinical research /study management environment
- English: Strong intermediate level
- Ability to work in a strong regulated environment within a quality management system (QMS)
- Advanced knowledge of software application (ex: Word, Excel, PowerPoint, Adobe Reader ...)
- Ability to organize and prioritize
- Able to produce work in teams and within a multi-disciplinary environment
- Basic Financial Knowledge- must be able to work with financial tracking tools
- Knowledge of Pharmaceutical Industry R&D
- Good knowledge of the Good Clinical Practices (GCP) or other clinical study regulations
-
Clinical Trial Associate
1 week ago
BioSpace Cambridge, United StatesJob Details · Clinical Trial Associate (Cell Therapy) · Cambridge, MA · About Us... · Obsidian Therapeutics is expanding the reach of TIL therapy. We are pioneering engineered tumor infiltrating lymphocyte (TIL) therapies to deliver transformative outcomes for patients suffering ...
-
Clinical Trial Associate
1 week ago
Obsidian Therapeutics Cambridge, United StatesOur Opportunity... · Obsidian Therapeutics is seeking a Clinical Trial Associate to work alongside the Clinical Development/Operations team to drive forward our clinical trials (currently recruiting patients with metastatic melanoma and non-small cell lung cancer). We're seeking ...
-
Clinical Trial Associate
2 weeks ago
Ipsen Pharma Cambridge, United StatesTitle:Clinical Trial AssociateCompany:Ipsen Bioscience, Inc.Job Description:Clinical Trial Associate (CTA)Purpose of the positionAssists and provides support to the members of the clinical operations study team in administrative activities in order to facilitate the overall manag ...
-
Clinical Trial Associate
6 days ago
Ipsen Pharma Cambridge, United StatesTitle: · Clinical Trial Associate · Company: · Ipsen Bioscience, Inc. · Job Description: · Clinical Trial Associate (CTA) · Purpose of the position Assists and provides support to the members of the clinical operations study team in administrative activities in order to fac ...
-
Senior Clinical Trial Associate
1 week ago
ONO PHARMA USA Cambridge, United StatesRole responsible for collaborating with and utilizing instructions/information from study managers or global project leaders to support Clinical Operations by ensuring the timely and effective implementation and maintenance of the clinical operational study documentation, in acco ...
-
Clinical Trials Associate
5 days ago
Monte Rosa Therapeutics, Inc Boston, Massachusetts, United States PermanentOverview: · We are seeking an energetic and highly motivated individual to join our Clinical Operations team. This position reports to the Head of Clinical Operations and is an opportunity to significantly contribute to the growth and development of a top-tier Biotech company. Th ...
-
Senior Clinical Trial Associate
2 weeks ago
ONO PHARMA USA Cambridge, United StatesRole responsible for collaborating with and utilizing instructions/information from study managers or global project leaders to support Clinical Operations by ensuring the timely and effective implementation and maintenance of the clinical operational study documentation, in acco ...
-
Clinical Trial Associate
5 days ago
Beacon Hill Waltham, United StatesTitle: CTA · Location: Waltham, MA Hybrid (3 days in the office a week is a must have) · Pay Rate: Open W2 · Position Overview: The CTA position will assist with daily clinical trial execution activities including the coordination of documents associated with the conduct of inves ...
-
Senior Clinical Trial Associate
2 weeks ago
Entrada Therapeutics Boston, United States Full timeThe Organization · What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. · O ...
-
BlueRock Therapeutics Cambridge, United StatesWho is BlueRock? · BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique cell+gene platform to direct cellular differentiation and genetically engineer cells to create a new generatio ...
-
Senior Clinical Trial Associate
2 weeks ago
Scipher Medicine Watertown, United StatesAt Scipher Medicine, we are revolutionizing the way medical treatments are prescribed. Leveraging our innovative platform, we ensure patients receive the treatment that matches their unique biological makeup. Our goal is to optimize treatment from day one and drive novel target d ...
-
Clinical Trial Associate
2 weeks ago
TotalMed Waltham, United StatesWe are seeking a Life Sciences Clinical Trial Associate for an assignment in Waltham Massachusetts. The Clinical Trial Associate (CTA) provides administrative support to the Clinical Operations Department. The primary purpose of the position is to facilitate efficient clinical tr ...
-
Clinical Trial Associate
1 week ago
Dragonfly Therapeutics Waltham, United StatesClinical Trial Associate · Dragonfly Therapeutics is seeking a highly motivated and experienced Clinical Trial Associate to provide administrative and operational support to Clinical Operations. In this role you will report to a Senior Clinical Trial Manager in Clinical Operatio ...
-
Clinical Trial Associate
1 hour ago
Thepharmadaily LLP Waltham, United StatesTitle: CTA · Location: Waltham, MA Hybrid (3 days in the office a week is a must have) · Pay Rate: Open W2 · Position Overview : The CTA position will assist with daily clinical trial execution activities including the coordination of documents associated with the conduct of inve ...
-
Clinical Trial Associate
1 week ago
CEDENT Boston, United StatesJob description · PURPOSE OF THE FUNCTION · As a member of the Clinical Trial Team (CTT), the Clinical Trial Associate Level 1 (CTA) will assist the Clinical Trial Managers (CTM) and other CTT functions if deemed necessary with the conduct of the assigned clinical trials, includi ...
-
Clinical Trial Associate
2 weeks ago
Beacon Hill Life Sciences - Boston Waltham, United StatesJob Description · Job DescriptionPosition Overview: · The CTA position will assist with daily clinical trial execution activities including the coordination of documents associated with the conduct of investigational clinical studies. The CTA will support the Clinical Trial Manag ...
-
Senior Clinical Trial Associate
1 week ago
Scipher Medicine Waltham, United StatesAt Scipher Medicine, we are revolutionizing the way medical treatments are prescribed. Leveraging our innovative platform, we ensure patients receive the treatment that matches their unique biological makeup. Our goal is to optimize treatment from day one and drive novel target d ...
-
The Steely Group Cambridge, United StatesReporting to the Director of Clinical Operations, this role is responsible for collaborating with and utilizing instructions/ information from study managers or global project leaders to support Clinical Operations by ensuring the timely and effectiv Clinical, Operations, Clinic, ...
-
Randstad US cambridge, United Statesclinical trial associate, clinical operations, infectious disease. · + cambridge , massachusetts (remote) · + posted 8 days ago · **job details** · summary · + $45 - $57.42 per hour · + contract · + bachelor degree · + category life, physical, and social science occupations · + r ...
-
Senior, Clinical Trials Associate
23 hours ago
Viridian Therapeutics Inc. Waltham, United States· At Viridian (NASDAQ: VRDN), we aim to advance new treatments for patients underserved by today's therapies. Our team consists of talented, entrepreneurial-minded professionals dedicated to improving the lives of patients suffering from serious diseases. We strive for data-driv ...
Clinical Trial Associate - Cambridge, United States - BioSpace
![BioSpace background](https://contents.bebee.com/companies/us/biospace/background-rMzbH.png)
Description
Job DetailsTitle:
Clinical Trial Associate
Company:
Ipsen Bioscience, Inc.
Job Description:
Clinical Trial Associate (CTA)
Purpose of the position
Be responsible for setting-up, monitoring verifying and archiving the clinical Trial Master File (TMF)
Experience:
This job is eligible to participate in our short-term incentives program.
At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more.
The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills.
IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.