TMF Specialist
Allen Spolden
Job Description
The TMF Specialist is responsible for overseeing the overall management and quality of essential clinical trial documents to ensure compliance with applicable regulatory and local requirements. This position will provide management and oversight of Trial Master File (TMF) filing activities to ensure audit and inspection readiness for clinical trials.
Responsibilities:
The TMF Specialist is responsible for overseeing the overall management and quality of essential clinical trial documents to ensure compliance with applicable regulatory and local requirements. This position will provide management and oversight of Trial Master File (TMF) filing activities to ensure audit and inspection readiness for clinical trials.
Responsibilities:
- Works with multi-functional study teams and vendors to ensure the maintenance of TMFs, both electronic and paper, in a state of inspection readiness.
- Maintains study-specific TMF Management Plan.
- Performing QC on TMF documents to ensure high quality per data quality standards and specified system guidelines
- Manages conduct of TMF quality reviews by cross-functional study team; driving to closure quality review findings.
- Supports the functional owners in the identification and management of the collection of study specific TMF content, (both sponsor and CRO).
- Assessing outstanding issues and following through to resolution
- Daily interaction with Clinical team, clinical project managers and members of the cross-functional study team.
- Plan, execute, and lead study-specific meetings.
- Follow international good clinical practice guidelines/regulations and standard operating procedures for executing clinical studies.
- Supports other trial-related operational activities as needed and assigned
- Bachelor's Degree Required
- 3-5 years of experience working in pharmaceutical/biotechnology or CRO organization in TMF management
- Working knowledge of VEEVA Vault
- Strong working knowledge of FDA & ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures
- Proficient in computer technology used in an office environment (Microsoft Word, Excel, and PowerPoint) and Share point
- Exceptional attention to detail.
- Ability to work independently and collaboratively with excellent written communication, oral communication, and organizational skills are required
- Strong interest in clinical trials and initiative to learn and participate in projects of increasing responsibility
- Highly responsive and proactive, a team player
- Excellent communication and organizational skills and the ability to work effectively in a high-paced, fast changing environment.
- Flexible attitude with respect to work assignments and new learning
- Conscientious, influential person with an outstanding work ethic and strong personal discipline
- Current authorization to work in the US
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the TMF Specialist in Cumberland, MD vacancy
$115k - $130k
Job Description Position Overview\n Inside Minds Therapy Center is actively seeking dedicated and qualified mental health professionals to join our expanding network as remote Licensed Mental Health Counselors. This fully remote position enables you to provide essential...SuggestedRemote jobFull timeHome officeInside Minds Therapy Center
Cumberland, MD21 days ago- .... This role supports leadership by ensuring the company’s financial records are reliable, timely, and decision-ready. The AP/AR Specialist plays a critical role in maintaining financial clarity, tracking performance, and supporting the company’s continued growth. Responsibilities...Suggested
- ...Merito Group - Immediate need for Temporary Staff For the MD State Police in various cities. SFS/Merito Group is seeking Facilities Specialist applicants. Duties Performs installation, operation, maintenance, and repair of facilities, institutional equipment and systems....SuggestedTemporary workImmediate start
$60k - $100k
Job Description Position Overview\n Gotham Enterprises Ltd is seeking a dedicated and compassionate Licensed Clinical Social Worker (LCSW-C) to join our remote team supporting our Detox Center in Cumberland, Maryland. This full-time position offers a unique opportunity...SuggestedFull timeRemote workFlexible hoursCompany Confidential
Cumberland, MD21 days ago$15.25 - $16.25 per hour
...Retail Zone Specialist Join our team and live the Ollie-tude! (Ollie's Core Values) BE A TEAM PLAYER - Associates are expected to be supportive and work together. BE CARING - How do I treat others with courtesy, dignity, and respect? BE VALUE OBSESSED - Live...SuggestedHourly payMinimum wageFull timePart timeWeekend workAfternoon shift$19 - $21 per hour
Job Description Job Description Overview LOVE TO TALK SPORTS? Dunham’s Sports, one of the largest full-line sporting goods chains in the U.S., was founded in 1937 as Dunham’s Bait & Tackle. Today we have over 250 stores in over 25 states from Maryland to Montana...Hourly payDunham's Sports
Cumberland, MD13 days ago$60k - $75k
Frito-Lay is seeking Delivery Drivers / Route Sales Representatives to deliver, stock, and merchandise Frito-Lay products at grocery stores, convenience stores, and retail locations on an assigned route. Drivers are responsible for operating a company delivery truck, delivering...Hourly payFull timeFRITO LAY
Cumberland, MD17 hours ago- Maintenance AssociateThe purpose of the Maintenance Associate is to ensure the cleanliness, safety, and overall upkeep of our store environment including the inside and outside of the building. Your attention to detail and proactive approach to maintenance activities will...Work at officeNight shiftWeekend work
Country Critters Veterinary Clinic
Cumberland, MD1 day ago $15.5 - $19 per hour
Retail Store Positions At The GIANT Company we're committed to making our stores and facilities better every day for our team members, customers, and communities. We put our customers first, do what's right, win together, and make ideas happen. As a team member here...Hourly payLocal areaShift workThe GIANT
Cumberland, MD4 days ago- Looking for coachable, hardworking, and motivated individuals interested in building an additional income stream. We are currently experiencing high demand and expanding into markets across the U.S. Training and support are provided, and qualified new associates may...Full timePart time
Success Partners
Wiley Ford, WV4 days ago - Checkout Team Associate WM Supercenter #2027 12500 Country Club Mall Rd Lavale, MD 21502-7553 7 open positions CP-2027-9020 $15.00 - $28.00/hr* Part time Full time Shift may start between 8:00am - 11:00am Shift may start between 1:00pm - 4:00pm Role Summary Front...Hourly payMinimum wageFull timeTemporary workPart timeShift workWeekend workAfternoon shift
Walmart
Cumberland, MD4 days ago $15.5 - $19 per hour
Retail Store Positions At The GIANT Company we're committed to making our stores and facilities better every day for our team members, customers, and communities. It's our secret recipe for success and it guides everything we do. We put our customers first, do what'...Hourly payLocal areaShift workThe GIANT
Cumberland, MD3 days ago$20 - $30 per hour
Associate Fire Alarm Inspector Sciens Building Solutions is seeking an Associate Fire Alarm Inspector to assist with inspection and maintenance capabilities. This position will work closely with our sales team, field project teams, and clients to ensure our customers...Hourly payTemporary workSciens Building Solutions
Cumberland, MD2 days ago- Lead Medical Laboratory TechnicianUPMC Western Maryland is hiring a Lead Medical Laboratory Technician to support the Core Lab! This full time position will work predominantly day shift but may be needed to cover shift hours based on department needs.This position assists...Full timeShift workDay shift
UPMC
Cumberland, MD1 day ago - Clinical Laboratory TechnologistPerform and analyze clinical laboratory tests in all laboratory disciplines by standard operating policies and procedures. Understand method principles, perform quality control, perform preventative maintenance, review, and analyze results...TraineeshipLocal area
WVU Medicine
Cumberland, MD2 days ago - Join Our Team in La Vale, MD This well-established, privately-owned audiology practice in La Vale, MD is now seeking a full-time Audiologist to join the team and contribute to their mission of delivering top-quality services in a supportive, collaborative environment...Full timePrivate practiceWork at officeLocal areaRelocation package
$15 - $18.3 per hour
Outside Recovery Associate The purpose of the Outside Recovery Associate is to facilitate efficient management of various projects in our outdoor merchandising area, with a core emphasis on assisting customers in loading their vehicles post-purchase. In addition, the...Hourly payWork at officeShift work- Online Order Filling Team Associate WM Supercenter #2027 12500 Country Club Mall Rd Lavale, MD 21502-7553 4 open positions CP-2027-9038 $15.00 - $28.00/hr* Part time Shift may start between 8:00am - 4:00pm Role Summary Online Order Filling associates have one ...Part timeShift work
$15 - $20 per hour
Job Title Task Associate Overview Experience a place of energy, passion, and excitement. A place where the joy of discovery and uncommon artistry blend to create exhilarating buying experiencesfor true beauty enthusiasts. At Ulta Beauty, we're transforming the...Full timePart timeWork experience placementLocal areaFlexible hoursShift workNight shiftWeekend workDay shiftAfternoon shiftEarly shift- Clinical Administrative Assistant Catholic Charities of Baltimore Villa Maria Behavioral Health Clinic is seeking a Clinical Administrative Assistant to provide a welcoming atmosphere for all who enter the Behavior Health Clinic (BHC). The work schedule is Monday Thursday...Work at office
- A retail store is seeking a Store Manager to oversee operations, lead staff, and ensure exceptional customer service. In this role, you'll be responsible for maximizing store profitability, managing inventory, and solving customer issues efficiently. The ideal candidate...Flexible hours
Par Mar Stores
Ridgeley, WV2 days ago - Summit Federal Services/Merito Group - Immediate need for Temporary Staff For the MD State Police in various cities. SFS/Merito Group is seeking Research Analyst applicants. Duties : Analyzes existing and potential product and service information, prospective...Temporary workWork experience placementImmediate start
Summit Federal Services LLC
Cumberland, MD17 hours ago $15.25 - $18.6 per hour
Recovery Associate The purpose of the Recovery Associate is to uphold the store's general look and arrangement. The primary emphasis lies in guaranteeing the correct return of merchandise to the sales floor, maintaining well-stocked shelves, and ensuring the store's...Hourly payWork at officeFlexible hoursShift work$16 - $19.5 per hour
Firearms Sales Associate The purpose of a Firearms Sales Associate is to provide exceptional customer service and expertise in firearms and related accessories. Your in-depth knowledge of firearms regulations, safety practices, and product features will contribute to...Hourly payLocal areaShift work$60.59k - $73.62k
Description Production Supervisor - Dark Meat Optix At Pilgrim’s, Safety Is A Condition , which means the safety of our team members comes first - always. In this key role, you'll serve as the frontline leader overseeing daily operations within our poultry production facility...WorldwideDay shiftPilgrim's
Cumberland, MD4 days ago- Benefits: Competitive salary Employee discounts Flexible schedule Signing bonus Training & development We are looking for someone who thrives in a welcoming, customer service-oriented environment with excellent communication skills. If you enjoy building strong relationships...Full timePart timeSeasonal workLocal areaRelocation packageFlexible hoursShift work
Jackson Hewitt
Cumberland, MD17 hours ago $22 per hour
Up to $22 per hour depending on experience and geographic location / local market demand Early Close / No late nights Great Work Life Balance Career Growth Opportunities Excellent Benefits including 401(k) with Employer Match Our Purpose We pride ourselves on serving...Hourly payCasual workLocal areaFlexible hoursShift workWeekend work$17.15 - $18.65 per hour
Overview Love to talk sports? Dunham's Sports, one of the largest full-line sporting goods chains in the U.S., was founded in 1937 as Dunham's Bait & Tackle. Today we have over 250 stores in over 25 states from Maryland to Montana. We'd like to talk with you about...Hourly payFull timePart timeFlexible hours- Department Lead Rural King Farm and Home Store strives to create a positive and rewarding workplace for our associates. We offer opportunities for growth, competitive benefits, a people first environment, and an opportunity to work alongside dedicated associates who...Seasonal workWork at officeFlexible hoursNight shiftWeekend work
$17.5 - $21.35 per hour
Rural King Farm and Home Store Job Opportunity Rural King Farm and Home Store strives to create a positive and rewarding workplace for our associates. We offer opportunities for growth, competitive benefits, a people first environment, and an opportunity to work alongside...Hourly payWork at officeFlexible hoursShift workNight shiftWeekend work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to TMF Specialist. Be the first to apply!
