- Prepares, processes, distributes, updates and maintains (filing and archiving) clinical study documentation in an electronic format. Ensures study compliance with OPUS SOPs and regulatory guidelines. Ensures TMF/eTMF is FDA-inspection ready at all times while the clinical trial is being conducted.
- Creates a documentation system (document files, binders, manuals, etc.) chronicling all incoming/outgoing clinical documentation. Provides oversight of Regulatory documents for site activation.
- Tracks study progress including site contracts, patient enrolment and patient status, and provides QC oversight of the CRO, TMF, QV Reports, Monitoring Visit Reports, Payments, Safety Alert acknowledgements, ICFs and timelines.
- Schedules Clinical Operations, study team, investigator and partner meeting, preparing/distributing required materials, and taking and distributing minutes, as required.
- Contributes to the 3rd party vendor qualification process (e.g. getting their financial condition utilizing a specific vendor, checking if there is an unacceptable risk of bribery or corruption using a specific checklist).
- Creates and/or reviews the study plans, specification documents, materials, and tools.
- Creates and maintains project databases (e.g., contact list, competitive study list), facilitates and tracks study payments following the internal approval process.
- Processes and tracks payments to vendors and study sites as appropriate. May be required to perform other duties, as assigned.
- Prepares, processes, distributes, updates and maintains (filing and archiving) clinical study documentation in an electronic format. Ensures study compliance with OPUS SOPs and regulatory guidelines by performing periodic quality control audits of any trial master file (TMF) maintained by the Service Provider (SP) before study initiation, during and at the end of a study. Ensures TMF/eTMF is FDA-inspection ready at all times while the clinical trial is being conducted. Provides access to the systems when applicable.
- Creates a documentation system chronicling all incoming/outgoing clinical documentation, maintains study supply documentation, reviews Study Folder regularly to ensure file accuracy and completeness, maintains study specific metric tracking and reviews Clinical Research Associate (CRA) field monitor reports and any necessary follow-up letters in relation to specific Study Monitoring Plan, contacting CROs and CRAs, as required. Provides oversight of Regulatory documents for site activation.
- Tracks study progress including site contracts, patient enrolment and patient status, and provides QC oversight of the CRO, TMF, QV Reports, Monitoring Visit Reports, Payments, Safety Alert acknowledgements, ICFs and timelines.
- Contributes to the development and updating of Clinical Operations SOPs and ensuring contribution to Clinical Operations process improvement within the clinical operations team and OPUS in general.
- Keeps abreast of the broad context of the industry related to commercial operations, regulations, best practices, relevant technologies and innovations. Understands the implications for the assigned area and implements innovative operations approaches to help ensure efficient operations and achieve mandate.
- Tracks and ensures training of the study team.
- Perform administrative tasks associated with the CTA role and responsibilities, as well as supporting other clinical operations team members.
- Associates Degree, or the equivalent in work experience, preferably in the life sciences.
- 3+ years of clinical trial management experience in the pharmaceutical/biotechnology industries, or with a Clinical Research Organizations (CROs) or a clinical research site
- 1+ years of Clinical Operations work experience.
- Knowledge and experience creating, organizing and maintaining eTMFs.
- Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook), email and internet.
- Knowledge of the Pharmaceutical Industry Clinical trial process (clinical trial conduct, documentation and reporting) in accordance with ICH/GCP and other regulatory compliance guidelines.
- Problem solving capabilities to align with independent assignments requiring limited supervision.
- Demonstrated ability to effectively manage and problem-solve several complex studies with rigorous timelines; provides high quality work resulting from attention to detail and accuracy; successfully interacts and communicates with multiple internal and external process owners.
- Strong verbal and written communication and interpersonal skills, with the ability to successfully articulate plans, results and analysis to project teams so as to build commitment.
- Work is generally sedentary in nature, but may require standing, walking, grasping, and lifting/moving up to 15 pounds (e.g., in order to shred documents, to maintain a neat and organized work environment, and to lift paper supplies, and large boxes and files).
- The noise level in the work environment is usually quiet.
- This role may require the incumbent to occasionally travel (domestic) to attend meetings. Travel will be scheduled based upon the needs of the business.
-
Clinical Trial Associate
3 weeks ago
Argenx Boston, United StatesPURPOSE 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, including the administrat ...
-
Clinical Trial Associate
2 weeks 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
ProKidney Boston, United States**Join us in developing pioneering therapies that aim to transform the treatment of CKD and change patients' lives. Our technology is designed to treat diseased kidneys using a patient's own cells and may prevent or delay dialysis or transplant.**: · - Study entry and updates to ...
-
Clinical Trial Associate
3 weeks ago
Rhythm Pharmaceuticals Inc. Boston, United StatesCompany Overview · Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the care of people living with rare melanocortin-4 receptor (MC4R) pathway diseases. Working at Rhythm means that you are part of a team that's passionate about transformin ...
-
Clinical Trial Associate
3 weeks ago
Obsidian Therapeutics Cambridge, United StatesClinical 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 from solid tum ...
-
Clinical Trial Associate
1 day 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
3 weeks 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 ...
-
Imbria Pharmaceuticals Boston, United StatesCompany Overview · Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cell's ability to produce energy in cardiova ...
-
Senior Clinical Trial Associate
3 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, Clinical Operations
3 weeks ago
Randstad Life Sciences US Cambridge, United StatesA major Pharmaceutical company, From accelerating drug discovery and early development to a rapidly expanding pipeline and a world-class team, delivering on the promise of treating infectious and other diseases. · SKILLS: · UNBLINDED study experience · Experience w/ IP documents ...
-
Clinical Trial Associate
3 weeks 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
3 weeks 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
3 weeks ago
BioSpace Cambridge, United StatesJob Details · Title: · Clinical Trial Associate · Company: · 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 ...
-
Clinical Trial Associate
3 weeks ago
Ortho Dermatologics Bridgewater, United StatesBausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurology, Ortho Dermatologics, Medical Aesthetics and Dentistry. We are delivering on ...
-
Associate Director, Clinical Trial Manager
2 weeks ago
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 generation o ...
-
Associate Director, Clinical Trial Manager
3 weeks ago
BlueRock Therapeutics Cambridge, United StatesThis position will lead a cross-functional clinical development team to ensure the successful planning, execution, and close-out of an upcoming Phase 1/2a clinical study and other studies, as needed. This individual will manage and oversee internal and external study activities, ...
-
Clinical Trial Associate
3 weeks ago
Rhythm Pharmaceuticals Boston, United StatesJob Description · Job DescriptionCompany Overview · Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or under ...
-
Clinical Trial Associate
3 weeks ago
Dragonfly Therapeutics, Inc. Watertown, 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 Operati ...
-
Sr, Clinical Trial Associate
4 weeks ago
Leap Therapeutics Cambridge, United StatesCompany Summary · Leap Therapeutics (Nasdaq: LPTX) is focused on developing targeted and immuno-oncology therapeutics. Leap's most advanced clinical candidate, DKN-01, is a humanized monoclonal antibody targeting the Dickkopf-1 (DKK1) protein. DKN-01 is being developed in patien ...
-
Clinical Trial Associates
3 weeks ago
Cardurion Pharmaceuticals, Inc Burlington, United StatesJob Description · Job DescriptionDescription:Why join Cardurion Pharma? · At Cardurion, we are advancing the understanding of signaling pathways that regulate heart cell function. Our programs seek to modulate these pathways to reverse the pathophysiological mechanisms that drive ...
Senior Clinical Trial Associate - Cambridge, United States - ONO PHARMA USA
Description
Role 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 accordance with study timelines from study initiation through to study closeout. The role:
Planning and Execution
Financial Outcome
Operation and Improvement
Innovation
Talent Development and Organization Growth
External/Internal Relationship
Educational Requirements
Experience
Technical Skills
Cognitive Skills
Language/Interpersonal Skills
Physical Demands
Work Environment
Business Travel
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of knowledge, skills and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function of this role. (US Only)
