Clinical Engagement Lead
2 weeks ago
Clinical Engagement Lead
Cambridge, MA
1 year contract
Job Description :
The site Engagement Leader builds partnerships and commitment by active elicitation of information on site specific processes and feedback on trial design. During the trial, sustained engagement encourages bidirectional communication and facilitates learning networks for enhanced site performance. Moreover, site and community partnerships are leveraged to create locally designed dissemination plans for broader scientific reach and impact.
Responsibilities:
To ensure study remains on each site top priority list using an innovative site centered approach, establishing preferred connections with sites. Works very closely with the Medical team, to review steering committee charter, publication rules (favorizing sites competitions) always in the context in strengthening site engagement to the study.
- Organizes regular Regional Group calls virtual & F2F (at sites, congress, IM)
o Attendance including sites personnel, CRO and client (PMs, CMLs, MSLs)
o Shares learning opportunity to troubleshoot challenges and streamline workflow. Encourage individual sites to lead discussion on area of expertise.
o Target presentations and publications including site team representatives and advocacy partners present at advocacy and local community organization conferences. Identify appropriate dissemination outlets.
o Disseminate lessons learned back to sites.
o Gather site feedback to help tailor future trainings.
- Individual sites call.
o With either PI or study coordinator to share findings provided, findings provided back to sites through in-person meetings, monthly calls, and tip-sheets.
o Give call- to actions to sites
- Actively contributes to Monthly Newsletters
o Study updates
o Recognize site personnel.
o Disseminate new research.
o Feature new site and/ or personnel.
o Highlight advocacy resources and events that site team can share with patients
- Actively contributes to new sites identification/ feasibility (incl. identifying/reaching to community sites with less competition to have them participating in the study)
- Actively contributes to recruitment boosting initiatives.
o Identifies Vendors responsible for recruitment boosting and actively participate to vendor contract and start up in the study
Qualifications:
- Scientific degree (Pharm.D.; Ph.D; MS...)
- 5-10 years experience in clinical research and clinical sites management in the pharmaceutical industry. Understanding of clinical trials and advanced knowledge of ICH-GCP, Clinical trials regulations, and applicable global and regional/country requirements.
- Decision-making and autonomy: Able to make sound decisions after identification of an issue and being able to make careful consideration of various courses of action towards resolution. Considers the short and long-term impact of those decisions in terms of risk to Ipsen from a regulatory, legal, financial and business acumen perspective. Influencing and motivational skills are needed for tactful and business smart communication with key internal- and external stakeholders.
- Is a team player and understands the roles and responsibilities of various groups managing clinical trials at client (Clinical, Medical, Medical Affaires, CRO representatives...), engages cross functionally to keep sites, client and CRO team members engaged around common study goals.
- Fluent in English with excellent communication skills
#TB_PH
-
Associate Director, Clinical Operations
2 weeks ago
Cambridge, United States Clinical Dynamix, Inc. Full timeRole: Associate Director, Clinical Operations We are looking for a energetic and passionate Associate Director, Clinical Operations who is excited to plan and lead timely and high quality oncology clinical trial execution. The ideal candidate has a track record of executing complex, on-time clinical trials at a biotech/pharma company and has begun working...
-
Clinical Monitoring Lead
2 weeks ago
Cambridge, United States TalentBurst, Inc. Full timeExperienced clinical scientist (PharmD, PhD, Nurse, etc..) in clinical development needed to support rare disease clinical trials from protocol development, study start up activities including investigator meetings, working closely with CRO and internal study team to meet study milestones, regulatory form creation and submission, ongoing data review,...
-
Real World Evidence Clinical Lead
2 weeks ago
Cambridge, United States Sarepta Therapeutics Inc. Full timeThe Real World Evidence (RWE) lead provides clinical leadership for evidence generation activities, supporting the integration of RWE into Sarepta key strategic initiatives. The role functions in a company matrix team environment interacting with several key stakeholder groups including; Clinical Development, Pharmacovigilance, Regulatory Affairs, Quality...
-
IT Operations Coordinator
1 week ago
Cambridge, United States Maxis Clinical Sciences Full timeJob DescriptionJob DescriptionClient's Global R&D Discovery IT team is offering a tremendous opportunity for an experienced IT Operations Coordinator to play a vital role in the delivery of technology solutions of value to meet the expanding needs of Client's global IT mission. Come join a growing team and we strive to advance solution delivery to a...
-
Program Coordinator
2 weeks ago
Cambridge, United States Maxis Clinical Sciences Full timeJob DescriptionJob DescriptionDescription:ACTUAL TITLE: IT Operations CoordinatorClient's Global R&D Discovery IT team is offering a tremendous opportunity for an experienced IT Operations Coordinator to play a vital role in the delivery of technology solutions of value to meet the expanding needs of Client's global IT mission. Come join a growing...
-
Associate Director, Clinical Sciences
1 week ago
Cambridge, United States BlueRock Therapeutics Full timeThe Associate Director, Clinical Sciences, Ophthalmology will be charged with providing medical and scientific support for BlueRock's Ophthalmology programs. Reporting to the Senior Director, Clinical Development, Ophthalmology, this role will work closely with clinical and program leads as well as other subject matter experts to expand and execute on the...
-
Vice President, Hematology Clinical Development
2 weeks ago
Cambridge, United States Third Rock Ventures Full timeFulcrum Therapeutics is seeking an experienced VP, Hematology Clinical Development to join the clinical development organization to provide medical/scientific expertise to advance our innovative product candidates in our non-malignant hematology pipeline, including the continued clinical development of FTX-6058. In this role, you will lead the clinical...
-
Vice President, Hematology Clinical Development
2 weeks ago
Cambridge, United States Fulcrum Therapeutics, Inc. Full timeCompany Overview Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's proprietary product engine identifies drug targets which can modulate gene expression to treat the known root cause of gene mis-expression. The...
-
Clinical Director
3 weeks ago
Cambridge, United States Empowered Staffing Full timeJob Description Job Description Empowered Staffing is partnered with Avenues Recovery Center, a nationwide network of drug and alcohol rehab centers with ten locations across five states. They are looking for a Clinical Director to join their team in Cambridge, MD to oversee the clinical operations of the 100-bed residential facility which offers inpatient...
-
Vice President, Clinical Development
2 weeks ago
Cambridge, United States Editas Medicine, Inc. Full timeAt Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...
-
Clinical Director
1 month ago
Cambridge, United States Empowered Staffing Full timeJob DescriptionJob DescriptionEmpowered Staffing is partnered with Avenues Recovery Center, a nationwide network of drug and alcohol rehab centers with ten locations across five states. They are looking for a Clinical Director to join their team in Cambridge, MD to oversee the clinical operations of the 100-bed residential facility which offers inpatient...
-
Vice President, Clinical Development
3 weeks ago
Cambridge, United States Editas Medicine Full timeJob DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....
-
Head, Clinical Pharmacology
4 days ago
Cambridge, United States Leap Therapeutics Full time**Head, Clinical Pharmacology**: **Company Summary**: **General Responsibilities**: ***The Head of Clinical Pharmacology will be responsible for developing and executing the clinical and non-clinical pharmacology strategies for compounds from the pre-clinical stage through first-in-human and into late-stage clinical development. They will support programs by...
-
Clinical Project Associate
2 weeks ago
Cambridge, United States Relay Therapeutics, Inc. Full timeThe Opportunity: As Clinical Project Associate, you will be accountable for providing clinical trial coordination support, along with implementing operational plans in accordance with regulatory guidelines and ICH/GCP standards. You will be an integrated member of the Relay Tx Clinical Development Operations team making key contributions to the execution of...
-
Clinical Project Manager
4 days ago
Cambridge, United States Relay Therapeutics Full timeThe Opportunity: As Clinical Project Manager, you will be accountable for managing clinical studies that will lead the biopharma industry in speed and quality of clinical study design and execution. You will be an integrated member of the Relay Tx scientific team, responsible for the execution of clinical studies that will translate Relay's innovative...
-
Lead and Assistant Guides
3 weeks ago
Cambridge, United States Charles River Recreation Inc - Paddle Boston Full timeJob DescriptionJob DescriptionResponsibilities: Lead and assist tours and custom group events in kayaks, canoes, or paddleboards from our different locations. Guides are responsible for trip preparation and planning, instruction, program safety, and providing a positive learning environment for participants. Additional work available assisting in the rental...
-
Clinical SAS Programmer
1 day ago
Cambridge, United States Katalyst Healthcares & Life Sciences Full time**Responsibilities**: - The SAS Programmer is responsible for developing and executing biostatistical (SAS) and data management related programs, processing data from various sources to support clinical and pharmaceutical projects and will include defining populations, creating variables, developing various statistical models, program debugging, as well as...
-
Sr Clinical Research Scientist
2 weeks ago
Cambridge, United States Aequor Full timeJob DescriptionJob DescriptionWe're looking only for a Senior level Clinical Research Scientist. Location is Hybrid, a minimum of 2 days onsite in Cambridge MA.This role is key to help the medical supervision of clinical studies by Clinical Research Directors (CRD) and to ensure scientific management of clinical studies to be performed by the Clinical &...
-
Director, Clinical Science
2 weeks ago
Cambridge, United States Foghorn Therapeutics Inc. Full timeOur Culture: Why work with us? At Foghorn Therapeutics, we believe in "People First, Mission Always." We put "People First" because we know our people are the key to everything we will accomplish. We value the diversity of background, ideas, perspectives and experiences that our team members bring to Foghorn Therapeutics - demonstrated by our community...
-
Senior Clinical Data Manager
1 month ago
Cambridge, United States AL Solutions Full timeJob DescriptionJob DescriptionAshley Smith-Brown is partnered with a rapidly growing International Life Science partner who are looking for an experienced Senior Clinical Data Manger to join their expanding Biometrics team.Position Overview:Ashley Smith-Brown is seeking an experienced and motivated Senior Clinical Data Manager to join their growing team. In...