job summary: Comp:
$110 to $135k, bonus (15 - 18%), stock options ($2300 - $4500) w/ great benefits. Relocation:
Relo available but they would like someone local if possible. If based in Houston they would have a flex schedule of working onsite/home. They would also be open to a candidate working completely remote if they live in the Philly/NJ/NY/Boston area. Start Date:
Senior Director - Clinical Science (based in Germany) Interview Process:
Phone Interview (Hiring Manager), Onsite Interview (Panel), Final (CMO & HR). New client who is motivated and expanding...
Randstad is the #1 HR Services company in the world and we are sourcing for a Senior Manager of Clinical Science in the Houston, TX area. This position will work in Houston, Texas and support our global multidisciplinary clinical sciences team. Working in close collaboration with the Clinical Operations Department and Medical Department, the position is responsible for various aspects of ongoing clinical trial program-related activities within various oncological indications. This is a direct hire position, relocation is available and can start immediately.
location: Houston, Texas
job type: Permanent
salary: $110,000 - 135,000 per year
work hours: 9 to 5
The main responsibilities of this position will include but are not limited to the following tasks:
- Acquire and utilize knowledge of clinical trial design to develop specific study concept sheets and protocols.
- Participate in protocol review discussions concerning scientific and procedural aspects of study design.
- In collaboration with Medical Writing and Clinical Operations, prepare study protocols, amendments, specific sections of study manuals and Investigator Meeting materials and other documents as needed with limited guidance and supervision.
- In collaboration with Data Management, contribute to the design and development of CRFs, Data Management Manuals, and Data Analysis Plans.
- With MD supervision, address questions regarding scientific and related procedural issues from Investigators.
- Contribute to the design, preparation and/or review of data listings, summary tables, study results, manuscripts and scientific presentations.
- Assist in the preparation and review of regulatory documents, IND Annual Reports, IND Safety Reports, Investigator Brochures.
- Interpret and summarize scientific information available in the published literature to integrate into new study development.
- Support priorities within the functional area.
- Represent supported projects at scientific conferences and advisory committees.
- Lead interactions with cooperative groups.
The qualifications for this position include, but are not limited to the following:
- Advanced degree in Clinical/Life Sciences REQUIRED.?Ph.D. Preferred.
- Three to Five years of experience in clinical development in the Pharmaceutical/Biotechnology industry.
- Ability to anticipate complex obstacles within a clinical study, and with guidance, implement solutions.
- Ability to coordinate teams and provide direction.
- Must be skilled in functional and cross-functional people and project management.
- Must be fully knowledgeable and skilled in the development and writing of regulatory documents including:
- Excellent verbal and written communication skills and interpersonal skills are required to maintain a working relationship with team members to ensure studies' scientific integrity.
skills: CRF, Medical science liaison, Data Analysis, Administration, CRFs, Data Validation Plan, Clinical Data Management, GCP (Good Clinical Practice), Clinical Study Design, CTMS, CTMS (Clinical Trial Management Systems), CTA, CTD Structure, Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Biostatistical Analysis
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.