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Manager / Associate Director Clinical Operations

Company: Amazon Workforce Staffing
Location: Cambridge
Posted on: September 17, 2020

Job Description:

Senior Manager / Associate Director Clinical Operations Company: Stoke Therapuetics

Location: Cambridge

Posted on: September 12, 2020

Job Description:

Associate Director Operations Management Jobs in Cambridge, MA.Jobs. Jobs. Interviews. Stoke Therapuetics5.0?. Senior Manager /Associate Director Clinical Operations. Stoke Therapeutics is abiotech company using RNA science to deliver a new generation ofgenetic medicines. By using a proprietary platform that restoresprotein levels, we take aim at severe genetic diseases that haveinadequate or no treatment options. Our first area of focus isDravet syndrome, a severe and progressive form of epilepsy thatstrikes children within the first year or two of life. For moreinformation, visit www.stoketherapeutics.com and follow Stoke onTwitter (@StokeTx).. Position Purpose:. Stoke is seeking anenthusiastic and highly motivated Associate Director to join theClinical Operations group. The successful candidate will beresponsible for leading clinical trial(s) and a team to make keydecisions related to the overall clinical trial executionstrategy.. Key Responsibilities Include:. Independently leadsprojects with focus on successful delivery of trials within time,quality, and budget expectations while adhering to strategy andperformance against key metrics and corporate goals.. Understandsthe broader industry and uses knowledge of competitive environmentto drive efficiency and sense of urgency through trial(s) whilemaintaining high quality standards. Sets the standard for trialmanagement at Stoke by demonstrating a high level of knowledge ofclinical operations methodologies, organizational, projectmanagement and leadership capabilities as well as increasedstrategic insight, decisiveness, and strong judgment. Leadscross-functional Clinical Study Team meetings. Makes certain thatthere is appropriate identification and ongoing assessment of risksand risk mitigation to ensure integrity of programs and to maintaintrial progress. Works closely with Clinical Development staff andpeers to ensure that study plans are aligned and in support ofbroader goals and objectives and that there is consistency inapproach to management of clinical trial programs. Ensures thatmultiple, novel ideas on how to deliver on clinical trials aregenerated and considered. Builds and implements resource planningand management skills, processes and standards while using anunderstanding and knowledge of different clinical phaserequirements to ensure effective resource management across trials.Oversees and manages CRO and multiple vendors including budgets andtimelines. Ensures outsourced resources, technology and proceduresused by external partners, vendors or CROs align with resourcingneeds within Clinical Operations. Ensures the voice of the patientis represented in the planning, design and conduct of clinicaltrials. Identifies opportunities and leads initiatives tostreamline processes and enhance productivity, efficiency andquality of outputs for Clinical Operations. Required Experience:.Minimum 5-7 years of industry experience.. § Bachelor's Degree in ahealth related or scientific discipline is required.. § Minimum 4years managing clinical studies.. § Proven track record in resourceplanning, forecasting, and budgeting.. § Expertise in globalregulatory and compliance requirements for clinical research,including but not limited to US CFR, EU CTD, and ICH GCP.. § RareDisease experience preferred but not required.. Demonstratesextensive clinical trials experience.. Demonstrates excellence incomplex trial management, effective management of multipleprojects/priorities, vendors and budgets.. Demonstratesunderstanding of pharmaceutical regulatory requirements andstrategic implications for clinical development operations..Demonstrates ability to lead multifunctional teams, mentor andcoach junior staff.. Excellent organizational, verbal, written andpresentation skills.. Travel:. Approximately 15% of this positionwill require travel.. Location(s):. This position will be primarilylocated in Cambridge, MA, and may also work occasionally fromBedford, MA.. Benefits & Compensation:. Stoke Therapeutics offerscomprehensive and competitive employee benefits, including medical,dental and vision insurance; life, long and short-term disabilityinsurance; Paid Primary Caregiver Leave; a 401K program withcompany match, and an Employee Stock Purchase Program (ESPP).Compensation will be highly competitive for the industry anddirectly commensurate with experience.. Interested candidatesshould apply directly to the position listed on Stokes website:.https://www.stoketherapeutics.com/join-our-team/. Get alerts tojobs like this, to your inbox.

Keywords: Stoke Therapuetics, Cambridge , Senior Manager / Associate Director Clinical Operations, Other , Cambridge, Massachusetts

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Keywords: Amazon Workforce Staffing, Cambridge , Manager / Associate Director Clinical Operations, Other , Cambridge, Massachusetts

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